80 results on '"Breneman D"'
Search Results
2. Once-weekly fluconazole (150, 300, or 450 mg) in the treatment of distal subungual onychomycosis of the fingernail
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Drake, L. A., Babel, D., Stewart, D. M., Rich, P., Ling, M. R., Breneman, D., Scher, R. K., Martin, A. G., Pariser, D. M., Pariser, R. J., Charles Ellis, Kang, S., Katz, H. I., Mcdonald, C. J., Muglia, J., Savin, R. C., Webster, G., Elewski, B. E., Leyden, J. J., Bucko, A. D., Tschen, E. H., Hanifin, J. M., Morman, M. R., Shupack, J. L., Levine, N., Lowe, N. J., Bergfeld, W. F., Camisa, C., Feingold, D. S., Konnikov, N., Odom, R. B., Aly, R., and Greer, D. L.
- Subjects
Adult ,Male ,Antifungal Agents ,Adolescent ,Dose-Response Relationship, Drug ,Arthrodermataceae ,Hand Dermatoses ,Dermatology ,Middle Aged ,Drug Administration Schedule ,Treatment Outcome ,Double-Blind Method ,Onychomycosis ,Humans ,Female ,Fluconazole ,Aged - Abstract
Onychomycosis is a prevalent infection of the nail caused primarily by dermatophytes. Fluconazole is active in vitro against the most common pathogens, penetrates into the nail bed, and is clinically effective in the treatment of a wide variety of fungal infections.The purpose of this study was to assess the safety and efficacy of oral fluconazole 150, 300, and 450 mg administered once weekly compared with placebo in the treatment of distal subungual onychomycosis of the fingernail caused by dermatophytes.This was a multicenter, randomized, double-blind, placebo-controlled study enrolling 349 patients with onychomycosis of the fingernails. Clinical and mycologic efficacy as well as measures of safety were assessed monthly for a maximum of 9 months of treatment, with additional safety visits occurring at weeks 2 and 6. For inclusion, patients were required to have clinically and mycologically documented onychomycosis of the fingernail caused by dermatophytes with at least 25% involvement of the target fingernail. After end of therapy, patients with improved or cured fingernails entered a blinded 6-month follow-up without drug treatment during which efficacy was assessed every 2 months. Efficacy was assessed by clinical (visual) and mycologic (microscopic and culture) measures. Clinical measures included assessments of the percentage of target nail involvement, measurement of the distance from the nail fold to the proximal onychomycotic border, and signs and symptoms of onychomycosis.Fluconazole was significantly superior to placebo in eradicating clinical and mycologic symptoms of onychomycosis, both at the end of active treatment and at 6 months after treatment (p=0.0001 for all efficacy measures). At the end of therapy, 91% to 100% of patients in the fluconazole groups were judged clinical successes, defined as reduction of the affected area of the target nail to less than 25% or cure, compared with 8% for placebo. Clinical cure rates at end of therapy were 76%, 85%, and 90% for fluconazole 150, 300, and 450 mg, respectively, compared with 3% for placebo. These clinical success and cure rates were largely maintained or improved during follow-up. Clinical relapse in cured patients during the follow-up period was very low (1.5% to 3.3%). Fluconazole demonstrated mycologic eradication rates of 89% to 100% at the end of treatment and 90% to 99% at the end of follow-up; for placebo the rates were 8% and 12%, respectively.Fluconazole administered once weekly is safe and effective in eradicating distal subungual onychomycosis of the fingernail caused by dermatophytes.
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- 1998
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3. A Phase Ii International, Multicenter Study of Oral Panobinostat (lbh589) in Patients With Refractory Cutaneous T-cell Lymphoma (ctcl)
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UCL - Autre, Bernengo, M. G., Vanaclocha, F., Duvic, M., Kuzel, T., Kerdel, F., Pinter-Brown, L., Bosly, André, Okada, C., Breneman, D., Zinzani, P. L., Becker, J., Hughey, L., Ardaiz, M., Zain, J., Zhang, L., Hirawat, S., Laird, G., Johnson, David, Prince, H. M., 13th Congress of the European-Hematology-Association, UCL - Autre, Bernengo, M. G., Vanaclocha, F., Duvic, M., Kuzel, T., Kerdel, F., Pinter-Brown, L., Bosly, André, Okada, C., Breneman, D., Zinzani, P. L., Becker, J., Hughey, L., Ardaiz, M., Zain, J., Zhang, L., Hirawat, S., Laird, G., Johnson, David, Prince, H. M., and 13th Congress of the European-Hematology-Association
- Published
- 2008
4. Effects of Centrifugal Forces on Particle Deposition for a Representative Seal Pin Between Two Blades
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Barringer, M. D., primary, Thole, K. A., additional, Breneman, D. L., additional, Tham, K.-M., additional, and Laurello, V., additional
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- 2013
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5. Effects of Centrifugal Forces on Particle Deposition for a Representative Seal Pin Between Two Blades
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Barringer, M. D., primary, Thole, K. A., additional, Breneman, D. L., additional, Tham, K.-M., additional, and Laurello, V., additional
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- 2012
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6. Phase II study of oral panobinostat (LBH589), a potent pan-deacetylase inhibitor, in patients with refractory Cutaneous T-cell Lymphoma (CTCL)
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Duvic, M., primary, Vanaclocha, F., additional, Bernengo, M. G., additional, Okada, C., additional, Breneman, D., additional, Zinzani, P. L., additional, Zhang, L., additional, Bopp, K., additional, Laird, G., additional, Hirawat, S., additional, and Prince, M., additional
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- 2008
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7. Vorinostat provides prolonged safety and clinical benefit to patients with advanced cutaneous t-cell lymphoma (CTCL)
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Olsen, E. A., primary, Duvic, M., additional, Breneman, D., additional, Pacheco, T. R., additional, Parker, S., additional, Vonderheid, E. C., additional, Ricker, J. L., additional, Rizvi, S., additional, Boileau, K., additional, and Geskin, L. J., additional
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- 2008
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8. Primary Cutaneous Immunocytoma Presenting with Diffuse Subclinical Involvement and Demonstrating Kappa and Lambda Light Chain Restrictions
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Lorenzo, C., primary and Breneman, D., additional
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- 2005
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9. Phase II study of pentostatin and intermittent high-dose recombinant interferon alfa-2a in advanced mycosis fungoides/Sézary syndrome.
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Foss, F M, primary, Ihde, D C, additional, Breneman, D L, additional, Phelps, R M, additional, Fischmann, A B, additional, Schechter, G P, additional, Linnoila, I, additional, Breneman, J C, additional, Cotelingam, J D, additional, and Ghosh, B C, additional
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- 1992
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10. Topical capsaicin for treatment of hemodialysis-related pruritus
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BRENEMAN, D, primary, SCOTTCARDONE, J, additional, BLUMSACK, R, additional, LATHER, R, additional, SEARLE, E, additional, and POLLACK, V, additional
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- 1992
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11. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part I, Efficacy
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Hanifin, J.M., Ling, M.R., Langley, R., Breneman, D., and Rafal, E.
- Abstract
A total of 632 adults with atopic dermatitis applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks in two randomized, double-blind studies. This report focuses on the efficacy of tacrolimus ointment in these studies. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. Evaluations included a physician's global evaluation of clinical response, %BSA affected, individual signs of atopic dermatitis, the Eczema Area and Severity Index (EASI) score, and the patient's assessment of pruritus. A 90% or greater improvement from baseline in disease status was observed for 6.6%, 27.5%, and 36.8% of patients in the vehicle, 0.03% tacrolimus ointment, and 0.1% tacrolimus ointment groups, respectively (P < .001), and 50% or better improvement was observed for 19.8%, 61.6%, and 72.7% of patients, respectively. Tacrolimus ointment-treated patients showed significantly greater improvement than vehicle-treated patients for all efficacy parameters evaluated, including the %BSA affected, the total score and individual scores for signs of atopic dermatitis, the patient's assessment of pruritus, and EASI score. The 0.1% concentration was more effective than the 0.03% concentration, particularly in patients with severe disease and/or extensive BSA involvement at baseline and in African Americans. Tacrolimus ointment is an effective therapy for the treatment of adult patients with atopic dermatitis on all skin regions including the head and neck.
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- 2001
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12. The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis
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Drake, L., Prendergast, M., Maher, R., Breneman, D., Korman, N., Satoi, Y., Beusterien, K.M., and Lawrence, I.
- Abstract
Background:: Atopic dermatitis can have detrimental effects on health-related quality of life (QOL). Objective:: Our purpose was to examine the QOL impact of tacrolimus ointment in patients with atopic dermatitis. Methods:: The Dermatology Life Quality Index (DLQI), Children's DLQI (CDLQI), and Toddler QOL Survey were used to assess QOL in adults (16 years or older), children (5-15 years), and toddlers (2-4 years) enrolled in 12-week, randomized, double-blind studies comparing two concentrations of tacrolimus ointment (0.03% and 0.1%) versus vehicle ointment for treatment of atopic dermatitis. QOL was assessed at baseline, week 3, and week 12/early discontinuation. Results:: Of the 985 patients enrolled, 91.5% had evaluable QOL data. Among adults, both tacrolimus ointment groups experienced improved QOL relative to the vehicle control group for all QOL scales (P < .001). Among children and toddlers, both tacrolimus ointment groups demonstrated significant QOL improvements relative to the vehicle control group (P < .05) for all but the Personal Relationships scale in the 0.03% tacrolimus ointment group among children. Conclusion:: Tacrolimus ointment is associated with significant QOL benefits in adults, children, and toddlers with atopic dermatitis.
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- 2001
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13. Mometasone Furoate 0.1%-Salicylic Acid 5 % Ointment Versus Mometasone Furoate 0.1% Ointment in the Treatment of Moderate-to-Severe Psoriasis: A Multicenter Study
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Koo, J., Cuffie, C. A., Tanner, D. J., Bressinck, R., Cornell, R. C., DeVillez, R. L., Edwards, L., Breneman, D. L., Piacquadio, D. J., and Guzzo, C. A.
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- 1998
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14. Pharmacokinetics of three once-weekly dosages of fluconazole (150, 300, or 450 mg) in distal subungual onychomycosis of the fingernail
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Savin, R.C., Drake, L., Babel, D., Stewart, D.M., Rich, P., Ling, M.R., Breneman, D., Scher, R.K., Martin, A.G., Pariser, D.M., Pariser, R.J., Ellis, C.N., Kang, S., Friedman, D., Katz, H.I., McDonald, C.J., Muglia, J., Webster, G., Elewski, B.E., Leyden, J.J., Bucko, A.D., Tschen, E.H., Hanifin, J.M., Morman, M.R., Shupack, J.L., Levine, N., Lowe, N.J., Bergfeld, W.F., Camisa, C., Feingold, D.S., Konnikov, N., Odom, R.B., Aly, R., Greer, D.L., and Hilbert, J.
- Abstract
Background: Fluconazole has proven to be safe and effective for a variety of superficial and systemic fungal infections. Preliminary analysis of extensive Phase III studies suggests that it is very effective for the treatment of onychomycosis. Its pharmacokinetic properties, including low molecular weight and high water-solubility, suggest a unique ability to penetrate the nail. This feature is likely to account in part for fluconazole's effectiveness in the treatment of onychomycosis. Objective: Determinations of plasma and fingernail concentrations of fluconazole were performed as part of a larger study comparing the safety and efficacy of once-weekly fluconazole (150, 300, and 450 mg) to placebo in the treatment of distal subungual onychomycosis of the fingernails caused by dermatophytes. The relationship between fluconazole concentrations and efficacy was also examined. Methods: Pharmacokinetic studies were performed by means of plasma and fingernail samples from 133 patients, a subset of 349 patients participating in a double-blind, placebo-controlled clinical trial of fluconazole administered in once-weekly doses of 150, 300, or 450 mg until cure of onychomycosis or for a maximum of 9 months. Blood and fingernail samples for pharmacokinetic analysis were taken at baseline, at week 2, and at monthly intervals during the treatment phase of the study. Patients considered clinically cured or improved also participated in a 6-month follow-up study. During this phase, patients were monitored and samples taken every 2 months. Results: Significant amounts of fluconazole were detected in the earliest fingernail samples taken (after 2 weeks of treatment). After two weekly doses, 30% to 33% of steady-state concentrations had been achieved in healthy nails and 22% to 29% in affected nails. Steady state was achieved in 3 to 5 months. Fluconazole concentration in nails as well as plasma followed dose-proportional pharmacokinetics. Nail:plasma ratios in affected nails were 0.4 to 0.6 at 2 weeks and 1.7 to 1.8 at 6 months. Fluconazole concentrations fell slowly after drug discontinuation and were still detectable 4 months after end of treatment. A statistically significant correlation was found between steady-state concentration and clinical and global outcomes. Conclusion: Fluconazole rapidly penetrates the fingernail, where it is retained at detectable levels for at least 4 months after drug discontinuation. A significant correlation exists between fluconazole concentration in the fingernails and clinical and global outcomes. (J Am Acad Dermatol 1998;38:S110-6.)
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- 1998
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15. Pharmacokinetics of three doses of once-weekly fluconazole (150, 300, and 450 mg) in distal subungual onychomycosis of the toenail
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Rich, P., Scher, R.K., Breneman, D., Savin, R.C., Feingold, D.S., Konnikov, N., Shupack, J.L., Pinnell, S., Levine, N., Lowe, N.J., Aly, R., Odom, R.B., Greer, D.L., Morman, M.R., Bucko, A.D., Tschen, E.H., Elewski, B.E., Smith, E.B., and Hilbert, J.
- Abstract
Background: Preliminary clinical data suggest that fluconazole is effective in the treatment of patients with onychomycosis. To design optimum dosage regimens, a better understanding of fluconazole's distribution into and elimination from nails is needed. Objective: The purpose of this study was to determine plasma and toenail concentrations of fluconazole. Methods: In this multicenter, randomized, double-blind investigation, fluconazole (150 mg, 300 mg, or 450 mg) or matching placebo was administered once a week for a maximum of 12 months to patients with onychomycosis of the toenail. A total of 151 subjects participated in the pharmacokinetic assessment. Blood samples and distal toenail clippings from both affected and healthy nails were obtained for fluconazole concentration determinations at baseline, at the 2-week visit, at each monthly visit until the end of treatment, and then at 2, 4, and 6 months (nail samples only at the latter two) after fluconazole was discontinued. Results: Fluconazole was detected in healthy and affected nails at the 2-week assessment in nearly all subjects. The median time to reach steady-state fluconazole concentrations in healthy nails was 4 to 5 months in the three fluconazole dose groups. In affected nails, steady-state fluconazole concentrations were achieved more slowly, with a median time of 6 to 7 months. At the 8-month assessment, affected toenail fluconazole concentrations were higher than corresponding plasma fluconazole concentrations, with ratios of 1.31 to 1.50 in the three active treatment groups. Toenail concentrations of fluconazole declined slowly after treatment was discontinued, with elimination half-lives of 2.5, 2.4, and 3.7 months for the 150, 300, and 450 mg doses, respectively. Measurable fluconazole concentrations were still present in toenails at 6 months after treatment in most subjects. Conclusion: Fluconazole penetrates healthy and diseased nails rapidly, yielding detectable concentrations after two weekly doses. Once it penetrates nail, fluconazole persists for up to 6 months or longer after therapy is stopped. These favorable pharmacokinetic characteristics support a once-weekly fluconazole dosage regimen for the treatment of patients with onychomycosis. (J Am Acad Dermatol 1998;38:S103-9.)
- Published
- 1998
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16. Once-weekly fluconazole (150, 300, or 450 mg) in the treatment of distal subungual onychomycosis of the toenail
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Scher, R.K., Breneman, D., Rich, P., Savin, R.C., Feingold, D.S., Konnikov, N., Shupack, J.L., Pinnell, S., Levine, N., Lowe, N.J., Aly, R., Odom, R.B., Greer, D.L., Morman, M.R., Bucko, A.D., Tschen, E.H., Elewski, B.E., and Smith, E.B.
- Abstract
Background: Onychomycosis is a prevalent infection of the nail caused primarily by dermatophytes. Fluconazole is active in vitro against the most common pathogens of onychomycosis, penetrates into the nail bed, and is clinically effective in the treatment of a wide variety of superficial fungal infections. Objective: The purpose of this study was to compare the efficacy and safety of three different doses of fluconazole (150, 300, and 450 mg) given orally once weekly to that of placebo in the treatment of distal subungual onychomycosis of the toenail caused by dermatophytes. Methods: In this multicenter, double-blind study, 362 patients with mycologically confirmed onychomycosis were randomized to treatment with fluconazole, 150, 300, or 450 mg once weekly, or placebo once weekly for a maximum of 12 months. To enter the study, patients were required to have at least 25% involvement of the target nail with at least 2 mm of healthy nail from the nail fold to the proximal onychomycotic border. Patients who were clinically cured or improved at the end of treatment were further evaluated over a 6 month follow-up period. At both the end of therapy and the end of follow-up, clinical success of the target nail was defined as reduction of the affected area to less than 25% or cure. Results: At the end of therapy, 86% to 89% of patients in the fluconazole treatment groups were judged clinical successes as defined above compared with 8% of placebo-treated patients. Clinical cure (completely healthy nail) was achieved in 28% to 36% of fluconazole-treated patients compared with 3% of placebo-treated patients. Fluconazole demonstrated mycologic eradication rates of 47% to 62% at the end of therapy compared with 14% for placebo. The rates at the end of follow-up were very similar, indicating that eradication of the dermatophyte was maintained over the 6-month period. All efficacy measures for the fluconazole groups were significantly superior to placebo (p = 0.0001); there were no significant differences between the fluconazole groups on these efficacy measures. The clinical relapse rate among cured patients over 6 months of follow-up was low at 4%. Fluconazole was well tolerated at all doses over the 12-month treatment period, with the incidence and severity of adverse events being similar between the fluconazole and placebo treatment groups. Mean time to clinical success in the fluconazole treatment groups was 6 to 7 months. This time frame may be used as a guideline for fluconazole treatment duration. Conclusion: The results of this study support the use of fluconazole in the treatment of distal subungual onychomycosis of the toenail caused by dermatophytes. Doses between 150 to 450 mg weekly for 6 months were clinically and mycologically effective as well as safe and well tolerated. (J Am Acad Dermatol 1998;38:S77-86.)
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- 1998
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17. Stream microcosm toxicity tests: predicting the effects of fenvalerate on riffle insect communities
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Pontasch, K. W. and Breneman, D. H.
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- *
INSECTS - Published
- 1994
18. Response to Total Skin Irradiation for Mycosis Fungoides Associated with Lymphomatoid Papulosis: Regarding Wilson et al., IJROBP 28:829-837; 1994
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Breneman, J. and Breneman, D.
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- 1995
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19. An uncommon presentation of cutaneous dissemination of gout.
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Aggarwal P, Gorell ES, Flood KS, Spicknall K, and Breneman D
- Abstract
Competing Interests: None disclosed.
- Published
- 2022
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20. Evaluation of the cost and efficacy of home-formulated sunscreens.
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Breneman A, Hancock J, Breneman C, Kadekaro AL, and Breneman D
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- Cost-Benefit Analysis, Humans, Patient Compliance, Skin drug effects, Skin radiation effects, Skin Care methods, Skin Neoplasms etiology, Sunscreening Agents administration & dosage, Sunscreening Agents economics, Titanium administration & dosage, Titanium chemistry, Ultraviolet Rays adverse effects, Zinc Oxide administration & dosage, Zinc Oxide chemistry, Skin Care economics, Skin Neoplasms prevention & control, Sunscreening Agents chemistry, Titanium economics, Zinc Oxide economics
- Published
- 2021
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21. A Case For Integrated Care In Senior Living.
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Katzmann L, Breneman D, and Byrne D
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- Aged, Aging, Geriatric Nursing, Humans, Medicare, Population Dynamics trends, United States, Assisted Living Facilities, Delivery of Health Care, Integrated, Health Services for the Aged
- Published
- 2015
22. Standards for genital protection in phototherapy units.
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Abdulla FR, Breneman C, Adams B, and Breneman D
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- Carcinoma, Squamous Cell prevention & control, Humans, Male, Masks, PUVA Therapy adverse effects, Phototherapy instrumentation, Radiation Protection instrumentation, Textiles, Genitalia, Male radiation effects, Phototherapy standards, Radiation Protection standards, Skin Neoplasms prevention & control, Ultraviolet Rays adverse effects
- Abstract
Background: Phototherapy is a useful therapy for many dermatologic disorders and is known for its low side-effect profile. However, one potential notable side effect is genital skin cancer. Unfortunately, no standards for genital protection currently exist for this preventable complication. Patients treated with phototherapy may already have a decreased quality of life because of their primary dermatologic disorder. Development of squamous cell carcinoma of the genitalia may certainly further affect the quality of life., Objective: The objective was to determine which readily available materials afford the best photoprotection of the male genitalia., Methods: Seven common materials used in phototherapy units for genital protection were placed over ultraviolet (UV) B and UVA monitors and placed in broadband UVB, narrowband UVB, and UVA full-body units. The percentage of light blocked was then calculated., Results: Blue and white cotton underwear, blue surgical towels, an athletic supporter with or without a cup, and the psoralen plus UVA pouch provided acceptable means of genital protection; however, surgical masks did not., Limitations: Only the most commonly used materials were tested in the phototherapy units. The materials were not of a single material type or similar masses. In addition, only one of each type of full-body phototherapy unit was used to obtain the data., Conclusion: Although a polyester composition provides better UV protection, factors such as low porosity and higher mass are intrinsic to decreasing the amount of UV penetration of any fabric. Of the commonly used objects, surgical masks do not provide sufficient protection to the genital area., (Copyright (c) 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)
- Published
- 2010
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23. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma.
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Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, and Geskin LJ
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- Aged, Female, Humans, Hydroxamic Acids adverse effects, Male, Middle Aged, Vorinostat, Antineoplastic Agents therapeutic use, Histone Deacetylase Inhibitors therapeutic use, Hydroxamic Acids therapeutic use, Lymphoma, T-Cell, Cutaneous drug therapy, Skin Neoplasms drug therapy
- Abstract
Introduction: Vorinostat, an orally active histone deacetylase inhibitor, was approved in October 2006 by the US Food and Drug Administration for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease during or after treatment with 2 systemic therapies., Patients and Methods: A multicenter, open-label phase IIb trial evaluated the activity and safety of vorinostat 400 mg orally daily in patients with > or = stage IB, persistent, progressive, or treatment-refractory mycosis fungoides or Sézary syndrome CTCL subtypes. We report the safety and tolerability of long-term vorinostat therapy in patients who experienced clinical benefit in the previous phase IIb study., Results: As of December 11, 2008, 6 of 74 patients enrolled in the original study had received vorinostat for > or = 2 years: median age, 65 years; median number of previous therapies, 2.5; median time from diagnosis to enrollment, 1.8 years. At enrollment into the continuation phase, 5 of the 6 patients had achieved an objective response, and 1 patient had prolonged stable disease. During the follow-up study, the most common drug-related grade 1-4 adverse events (AEs) were diarrhea, nausea, fatigue, and alopecia (6, 5, 4, and 3 patients, respectively). Incidence of grade 3/4 AEs was low: anorexia (n = 1), increased creatinine phosphokinase (n = 1), pulmonary embolism (n = 1), rash (n = 1), and thrombocytopenia (n = 1). Five patients have discontinued the study drug, and 1 patient is continuing therapy., Conclusion: This post hoc subset analysis provides evidence for the long-term safety and clinical benefit of vorinostat in heavily pretreated patients with CTCL, regardless of previous treatment failures.
- Published
- 2009
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24. Adult patients with moderate atopic dermatitis: tacrolimus ointment versus pimecrolimus cream.
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Abramovits W, Fleischer AB Jr, Jaracz E, and Breneman D
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- Administration, Cutaneous, Adult, Female, Follow-Up Studies, Humans, Male, Middle Aged, Ointments, Prospective Studies, Severity of Illness Index, Single-Blind Method, Tacrolimus administration & dosage, Tacrolimus adverse effects, Dermatitis, Atopic drug therapy, Tacrolimus analogs & derivatives, Tacrolimus therapeutic use
- Abstract
The objective of this study was to compare the efficacy and safety of tacrolimus ointment and pimecrolimus cream in adults with moderate atopic dermatitis (AD). A randomized, investigator-blinded, 6-week, multicenter study enrolled patients (> or =16 years) with mild to very severe AD. Patients with moderate AD at baseline were analyzed. At study completion, tacrolimus ointment-treated patients had significantly greater improvement in Eczema Area Severity Index score compared with pimecrolimus cream-treated patients (59% versus. 43% reduction, respectively; P=.01). Significantly more tacrolimus ointment-treated patients than pimecrolimus cream-treated patients improved by 1 or more grades on the Investigators' Global Atopic Dermatitis Assessment (P<.02). A total of 5 pimecrolimus cream-treated patients discontinued the study early due to lack of efficacy compared with no tacrolimus ointment-treated patients (P=.02). Overall, reported adverse events occurred at a similar frequency for both treatment groups. Tacrolimus ointment is more effective than pimecrolimus cream in the management of adults with moderate AD.
- Published
- 2008
25. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle.
- Author
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Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, and Hanifin JM
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- Adolescent, Child, Child, Preschool, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Ointments, Time Factors, Dermatitis, Atopic prevention & control, Immunosuppressive Agents administration & dosage, Tacrolimus administration & dosage
- Abstract
Background: Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated., Objective: We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse., Methods: Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days., Results: A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P = .003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P = .037)., Limitations: Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial., Conclusions: Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.
- Published
- 2008
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26. Hydrocortisone butyrate 0.1% lotion in the treatment of atopic dermatitis in pediatric subjects.
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Matheson R, Kempers S, Breneman D, Draelos Z, Johnson CE, Loss R, Hogan DJ, Schoenfeld R, Checketts S, Kircik L, Fivenson D, Hebert AA, Williams J, Hamlin R, Groisser D, and Piacquadio D
- Subjects
- Administration, Cutaneous, Adolescent, Child, Child, Preschool, Dermatitis, Atopic complications, Double-Blind Method, Female, Humans, Hydrocortisone adverse effects, Hydrocortisone therapeutic use, Immunosuppressive Agents adverse effects, Infant, Male, Pruritus drug therapy, Pruritus etiology, Severity of Illness Index, Treatment Outcome, Dermatitis, Atopic drug therapy, Hydrocortisone analogs & derivatives, Immunosuppressive Agents therapeutic use
- Abstract
Background: Hydrocortisone butyrate (HCB) is currently marketed as a cream, ointment, and solution. A new lotion formulation of hydrocortisone butyrate 0.1% (Locoid lotion) has been developed and evaluated., Objective: The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD)., Methods: In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. "Treatment success" was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events., Results: Analyses of the final PGA score showed a significant treatment effect (P <.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable., Limitations: The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD., Conclusion: Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.
- Published
- 2008
27. Persistent agmination of lymphomatoid papulosis: an equivalent of limited plaque mycosis fungoides type of cutaneous T-cell lymphoma.
- Author
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Heald P, Subtil A, Breneman D, and Wilson LD
- Subjects
- Adolescent, Adult, Aged, 80 and over, Female, Humans, Ki-1 Antigen biosynthesis, Lymphomatoid Papulosis metabolism, Lymphomatoid Papulosis pathology, Male, Middle Aged, Lymphoma, T-Cell, Cutaneous etiology, Lymphomatoid Papulosis complications, Mycosis Fungoides etiology
- Abstract
Background: Lymphomatoid papulosis (LyP) is a self-healing eruption in the spectrum of CD30+ lymphoproliferative disorders. The most common lymphoproliferative disorder associated with LyP is the most common form of cutaneous T-cell lymphoma: mycosis fungoides., Objective: We sought to describe a distinct entity on the spectrum of CD30+ lymphoproliferative disorders., Results: Seven patients presented with similar findings. Within a well-circumscribed area, the size and location of a patch of mycosis fungoides, these patients had continual eruptions of papulonodules that were histologically typical of LyP. The localized areas of involvement were treated as oligolesional mycosis fungoides and long-standing remissions occurred even after years of experiencing continuous localized eruptions. The clinical and histologic findings are reviewed and presented in a way to further the identification of patients with this entity., Limitations: This distinct entity is only defined by 7 patients., Conclusion: The agmination of LyP-like papulonodules confined to a discrete circumscribed area is a distinct clinical subset within the spectrum of CD30+ lymphoproliferative disorders. The behavior of this entity is that of a progressive lymphoma that warrants therapy.
- Published
- 2007
- Full Text
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28. Phase II clinical trial of bexarotene gel 1% in psoriasis.
- Author
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Breneman D, Sheth P, Berger V, Naini V, and Stevens V
- Subjects
- Adult, Aged, Aged, 80 and over, Bexarotene, Dermatologic Agents administration & dosage, Dermatologic Agents adverse effects, Drug Administration Schedule, Female, Gels, Humans, Male, Middle Aged, Psoriasis pathology, Quality of Life, Severity of Illness Index, Skin pathology, Surveys and Questionnaires, Tetrahydronaphthalenes administration & dosage, Tetrahydronaphthalenes adverse effects, Treatment Outcome, Dermatologic Agents therapeutic use, Psoriasis drug therapy, Tetrahydronaphthalenes therapeutic use
- Abstract
We report the results of a nonrandomized, open-label pilot trial investigating the safety, tolerability, and efficacy of bexarotene gel 1% in treating chronic mild to moderate plaque psoriasis. Twenty-four adults with mild to moderate stable plaque psoriasis involving 15% or less of their body surface were enrolled. Patients applied bexarotene gel 1%, using an application frequency escalation regimen, starting at once every other day and increasing to 4 times daily as tolerated and beneficial for up to 24 weeks. The primary efficacy instrument was a Physician's Global Assessment (PGA) score evaluating the overall response to treatment. This utilized individual signs of psoriasis and the percent of body surface area involvement. Safety assessments included physical examinations, recording of adverse events, and laboratory safety evaluations. Fifteen out of 24 enrolled patients (63%) achieved at least 50% improvement by PGA score at 2 or more consecutive visits, and 6 (24%) achieved clearing of 90% or more. Six patients maintained a response throughout 8 weeks of follow-up. An increased response appeared to correlate with a higher frequency of gel application. Adverse events occurred primarily at application sites and were mild or moderate in severity. Bexarotene gel 1% was active in treating mild to moderate plaque psoriasis with achievement of durable responses in some patients and was well-tolerated. A randomized, placebo-controlled study would be useful in confirming these results.
- Published
- 2007
29. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis.
- Author
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Fleischer AB Jr, Abramovits W, Breneman D, and Jaracz E
- Subjects
- Administration, Cutaneous, Adult, Dermatitis, Atopic pathology, Double-Blind Method, Female, Humans, Immunologic Factors administration & dosage, Male, Ointments, Prospective Studies, Severity of Illness Index, Tacrolimus administration & dosage, Treatment Outcome, United States, Dermatitis, Atopic drug therapy, Immunologic Factors therapeutic use, Tacrolimus analogs & derivatives, Tacrolimus therapeutic use
- Abstract
Objective: To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD)., Methods: A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator-blinded, 6-week study., Results: Tacrolimus-treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus-treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p=0.0002). Treatment success was also significantly greater among the tacrolimus-treated patients compared with pimecrolimus-treated patients (40% vs 22% at study end; p=0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p=0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application-site burning and application-site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the study due to lack of efficacy (10 vs 1, p=0.005)., Conclusion: Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
- Published
- 2007
- Full Text
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30. Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis.
- Author
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Chapman MS, Schachner LA, Breneman D, Boguniewicz M, Gold MH, Shull T, Linowski GJ, and Jaracz E
- Subjects
- Adolescent, Adult, Aged, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Ointments, Randomized Controlled Trials as Topic, Treatment Outcome, Dermatitis, Atopic drug therapy, Immunosuppressive Agents therapeutic use, Tacrolimus therapeutic use
- Abstract
Background/objective: Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD., Methods: Two identically designed, independent, randomized, double-blind, 6-week studies--one pediatric and one adult--in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as "clear" or "almost clear" on the Investigator's Global AD Assessment) at end of study., Results: As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle ( P = .003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P = .03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging., Conclusion: Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action.
- Published
- 2005
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31. Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream.
- Author
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Breneman D, Fleischer AB Jr, Kaplan D, Lebwohl M, Miller B, Pariser D, Rist T, Swinyer L, Liu Y, and Foley V
- Subjects
- Administration, Topical, Adolescent, Adult, Aged, Aged, 80 and over, Chemistry, Pharmaceutical, Child, Dermatitis, Atopic pathology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Single-Blind Method, Clobetasol administration & dosage, Clobetasol analogs & derivatives, Dermatitis, Atopic drug therapy, Emollients administration & dosage
- Abstract
Atopic dermatitis (AD) is a chronic inflammatory and pruritic skin disorder marked by alternating periods of relapse and remission. This multicenter, randomized, active- and vehicle-controlled, investigator-blinded study compared the efficacy and safety of clobetasol propionate lotion to clobetasol propionate cream formulation and lotion vehicle in the treatment of moderate to severe AD. A total of 229 subjects applied treatment twice-daily for 2 weeks. Clobetasol propionate lotion was significantly more effective than its lotion vehicle at 2 weeks and comparable to the cream formulation. Clinical success after a 2-week, treatment-free follow-up period was greater in the clobetasol propionate lotion group than in the cream group. Clobetasol propionate lotion is effective, safe, well tolerated and offers a better remission profile in the treatment of moderate to severe AD as compared to clobetasol propionate emollient cream.
- Published
- 2005
32. Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis.
- Author
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Jarratt M, Breneman D, Gottlieb AB, Poulin Y, Liu Y, and Foley V
- Subjects
- Administration, Topical, Adult, Anti-Inflammatory Agents administration & dosage, Anti-Inflammatory Agents adverse effects, Clobetasol administration & dosage, Clobetasol adverse effects, Double-Blind Method, Female, Hair Preparations, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Anti-Inflammatory Agents therapeutic use, Clobetasol therapeutic use, Psoriasis drug therapy, Scalp Dermatoses drug therapy
- Abstract
Psoriasis is a chronic, papulosquamous condition that affects up to 2% of the U.S. population. Approximately 50% of patients with psoriasis have involvement of the scalp. This was a multicentre, randomized, vehicle-controlled, double-masked and parallel-group study. The aim was to evaluate the efficacy and safety of clobetasol propionate shampoo, 0.05% versus its corresponding vehicle in subjects aged 12 years and older with moderate to severe scalp psoriasis over a treatment period of 4 weeks. Recurrence of scalp psoriasis was assessed during a two week follow-up period. A total of 142 subjects were treated. Results after 4 weeks demonstrated that clobetasol propionate shampoo, 0.05% was with a similar safety profile significantly more effective than its vehicle. The novel short contact shampoo formulation of clobetasol propionate is convenient and efficacious and minimizes systemic exposure while being efficient, safe and well-tolerated in the treatment of moderate to severe scalp psoriasis.
- Published
- 2004
33. Double-blind, randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin topical gel in the treatment of patients with moderate to severe rosacea.
- Author
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Breneman D, Savin R, VandePol C, Vamvakias G, Levy S, and Leyden J
- Subjects
- Administration, Cutaneous, Adolescent, Adult, Aged, Double-Blind Method, Drug Administration Schedule, Female, Gels, History, 17th Century, Humans, Male, Prospective Studies, Rosacea pathology, Severity of Illness Index, Treatment Outcome, United States, Anti-Bacterial Agents administration & dosage, Benzoyl Peroxide administration & dosage, Clindamycin administration & dosage, Rosacea drug therapy
- Abstract
Background: Systemic antibiotics such as tetracycline are well accepted as effective in treating the inflammatory papular/pustular phase of rosacea but may be associated with systemic side-effects. Few controlled data on the use of topical antibiotics in rosacea are available., Objective: We evaluated the efficacy and tolerability of a fixed combination of 5% benzoyl peroxide and 1% clindamycin in a topical gel for the treatment of rosacea. Methods This was a 12-week, double-blind, vehicle-controlled, randomized, prospective, parallel-group study in 53 patients with moderate to severe rosacea., Results: The mean percentage reduction in papules and pustules from baseline to the end of treatment was 71.3% in the benzoyl peroxide/clindamycin group (n = 26) and 19.3% in the vehicle group (n = 26; P = 0.0056). A significant (P = 0.0141) difference in favor of benzoyl peroxide/clindamycin was evident by the third week of treatment. Severity scores for erythema, papules/pustules, and flushing/blushing decreased more with benzoyl peroxide/clindamycin than with vehicle. Overall rosacea severity, Physician Global Assessment, and Patient's Global Assessment at the end of treatment were all significantly improved with benzoyl peroxide/clindamycin compared with vehicle (P = 0.0101, 0.0026, and 0.0002, respectively). Application site reactions were reported in four patients (14.8%) in the benzoyl peroxide/clindamycin group., Conclusion: A once-daily topical application of a combination of 5% benzoyl peroxide and 1% clindamycin is effective and well tolerated in patients with moderate to severe rosacea.
- Published
- 2004
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34. Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma.
- Author
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Breneman D, Duvic M, Kuzel T, Yocum R, Truglia J, and Stevens VJ
- Subjects
- Adult, Aged, Aged, 80 and over, Anticarcinogenic Agents adverse effects, Anticarcinogenic Agents therapeutic use, Bexarotene, Female, Gels, Humans, Lymphoma, T-Cell pathology, Male, Middle Aged, Neoplasm Staging, Safety, Skin Neoplasms pathology, Tetrahydronaphthalenes adverse effects, Tetrahydronaphthalenes therapeutic use, Treatment Outcome, Anticarcinogenic Agents administration & dosage, Lymphoma, T-Cell drug therapy, Skin Neoplasms drug therapy, Tetrahydronaphthalenes administration & dosage
- Abstract
Objective: To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL)., Design: Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene gel., Setting: Three university-based clinics., Participants: Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL., Interventions: Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose., Main Outcome Measures: Patients were followed for efficacy and safety, and treatment continued as long as they benefited. Response (> or =50% improvement) was evaluated by the Physician's Global Assessment of cutaneous disease and by an overall severity assessment of cutaneous disease, including signs of CTCL and area involved., Results: Most patients tolerated topical bexarotene at 1% gel twice daily for routine use. Adverse events were generally mild to moderate in severity and were confined to treatment sites. Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure. Patients achieved an overall response rate of 63% and a clinical complete response rate of 21%. Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks. Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%)., Conclusions: Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.
- Published
- 2002
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35. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results.
- Author
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Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, and Yocum RC
- Subjects
- Adult, Aged, Aged, 80 and over, Bexarotene, Female, Humans, Lymphoma, T-Cell, Cutaneous mortality, Male, Middle Aged, Quality of Life, Tetrahydronaphthalenes adverse effects, Tetrahydronaphthalenes pharmacokinetics, Anticarcinogenic Agents therapeutic use, Lymphoma, T-Cell, Cutaneous drug therapy, Tetrahydronaphthalenes therapeutic use
- Abstract
Purpose: Cutaneous T-cell lymphomas (CTCL) are malignancies of T cells appearing as skin lesions and are responsive to retinoid therapy. Safety and efficacy of a novel RXR-selective retinoid (rexinoid) bexarotene (Targretin, LGD1069; Ligand Pharmaceuticals Inc, San Diego, CA) was evaluated as a single-agent oral therapy administered once daily in an open-label study in patients with refractory advanced-stage CTCL., Patients and Methods: Ninety-four patients with biopsy-confirmed CTCL in advanced stages (IIB-IVB) were enrolled at 26 centers. Fifty-six patients received an initial dose of 300 mg/m2/d oral bexarotene and 38 started at more than 300 mg/m2/d., Results: Clinical complete and partial responses were reported by Primary End point Classification for the study in 45% (25 of 56) of patients enrolled at 300 mg/m2/d dosing. At more than 300 mg/m2/d, 55% (21 of 38) of patients responded, including 13% (five of 38) clinical complete. For the 300 mg/m2/d initial dose group, the rate of relapse after response was 36% and the projected median duration of response was 299 days. Improvements were also seen in overall body-surface area involvement, median index lesion surface area, adenopathy, cutaneous tumors, pruritus, and CTCL-specific quality of life. The most frequent drug-related adverse events included hypertriglyceridemia (associated rarely with pancreatitis), hypercholesterolemia, hypothyroidism, and headache., Conclusion: Bexarotene is the first in a novel class of pharmacologic agents, the RXR-selective retinoids, or rexinoids. Bexarotene is orally administered, safe, and generally well tolerated with reversible side effects, and is effective for the treatment of advanced, refractory CTCL.
- Published
- 2001
- Full Text
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36. The effect of antibacterial soap with 1.5% triclocarban on Staphylococcus aureus in patients with atopic dermatitis.
- Author
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Breneman DL, Hanifin JM, Berge CA, Keswick BH, and Neumann PB
- Subjects
- Adolescent, Adult, Aged, Analysis of Variance, Child, Double-Blind Method, Female, Humans, Male, Middle Aged, Staphylococcus aureus isolation & purification, Anti-Infective Agents, Local administration & dosage, Baths, Carbanilides administration & dosage, Dermatitis, Atopic microbiology, Staphylococcal Skin Infections drug therapy, Staphylococcus aureus drug effects
- Abstract
This double-blind study determined whether daily bathing with an antibacterial soap would reduce the number of Staphylococcus aureus on the skin and result in clinical improvement of atopic dermatitis. For 9 weeks, 50 patients with moderately severe atopic dermatitis bathed daily with either an antimicrobial soap containing 1.5% triclocarban or the placebo soap. They also used a nonmedicated moisturizer and 0.025% triamcinolone acetonide cream as needed, but the availability of the corticosteroid cream was discontinued after 6 weeks. The antimicrobial soap regimen caused significantly greater improvement in the severity and extent of skin lesions than the placebo soap regimen, which correlated with reductions both in S aureus in patients with positive cultures at baseline and in total aerobic organisms. Outcome measures included reductions in S aureus, total aerobic organisms, and dermatologic assessments. Overall, daily bathing with an antibacterial soap was well tolerated, provided clinical improvement, and reduced levels of skin microorganisms.
- Published
- 2000
37. Diffuse and progressive papules and nodules.
- Author
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Adamick CM and Breneman DL
- Subjects
- Aged, Biopsy, Diagnosis, Differential, Humans, Leukemia, Monocytic, Acute pathology, Male, Skin Diseases, Papulosquamous pathology, Leukemia, Monocytic, Acute diagnosis, Leukemic Infiltration pathology, Skin pathology, Skin Diseases, Papulosquamous diagnosis
- Published
- 2000
38. The addition of topical doxepin to corticosteroid therapy: an improved treatment regimen for atopic dermatitis.
- Author
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Berberian BJ, Breneman DL, Drake LA, Gratton D, Raimir SS, Phillips S, Sulica VI, and Bernstein JE
- Subjects
- Administration, Cutaneous, Adrenal Cortex Hormones adverse effects, Adult, Antipruritics administration & dosage, Antipruritics adverse effects, Double-Blind Method, Doxepin administration & dosage, Doxepin adverse effects, Drug Therapy, Combination, Female, Humans, Hydrocortisone therapeutic use, Male, Pain chemically induced, Skin drug effects, Skin pathology, Sleep Stages drug effects, Treatment Outcome, Triamcinolone therapeutic use, Adrenal Cortex Hormones therapeutic use, Antipruritics therapeutic use, Dermatitis, Atopic drug therapy, Doxepin therapeutic use
- Published
- 1999
- Full Text
- View/download PDF
39. Tazarotene 0.1% gel plus corticosteroid cream in the treatment of plaque psoriasis.
- Author
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Lebwohl MG, Breneman DL, Goffe BS, Grossman JR, Ling MR, Milbauer J, Pincus SH, Sibbald RG, Swinyer LJ, Weinstein GD, Lew-Kaya DA, Lue JC, Gibson JR, and Sefton J
- Subjects
- Administration, Cutaneous, Adrenal Cortex Hormones administration & dosage, Adrenal Cortex Hormones adverse effects, Adult, Canada, Drug Therapy, Combination, Female, Gels, Humans, Keratolytic Agents administration & dosage, Keratolytic Agents adverse effects, Male, Middle Aged, Nicotinic Acids administration & dosage, Nicotinic Acids adverse effects, Ointments, Severity of Illness Index, Time Factors, Treatment Outcome, United States, Adrenal Cortex Hormones therapeutic use, Keratolytic Agents therapeutic use, Nicotinic Acids therapeutic use, Psoriasis drug therapy
- Abstract
Background: Topical corticosteroids are often used in the treatment of psoriasis, but long-term use may be associated with serious adverse events such as tachyphylaxis or atrophy of the skin. Tazarotene, a new topical retinoid, has demonstrated significant clinical benefits but can cause mild to moderate local irritation., Objective: We evaluate whether a combination treatment of topical tazarotene and a topical corticosteroid would increase efficacy while reducing the incidence of local adverse events associated with a topical retinoid., Methods: Three hundred patients enrolled in an investigator-masked study were randomly assigned to 1 of 4 treatment groups: tazarotene 0.1% gel in combination with placebo cream, or with a low-, mid-, or high-potency corticosteroid cream, for 12 weeks of treatment and a posttreatment follow-up at week 16., Results: Tazarotene 0.1% gel in combination with a mid- or high-potency corticosteroid, when compared with tazarotene plus placebo cream, achieved significantly greater reductions in scaling, erythema, and overall lesional severity, and a decreased incidence of adverse events., Conclusion: All tazarotene combinations (including tazarotene plus placebo) were highly effective in rapidly reducing the severity of psoriasis. Combining tazarotene with a topical corticosteroid increased efficacy while reducing the incidence of local adverse events.
- Published
- 1998
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40. Cutaneous pseudolymphomas.
- Author
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Ploysangam T, Breneman DL, and Mutasim DF
- Subjects
- Diagnosis, Differential, Humans, Immunohistochemistry, Immunophenotyping, Pseudolymphoma diagnosis, Pseudolymphoma etiology, Pseudolymphoma immunology, Pseudolymphoma pathology, Skin Diseases diagnosis, Skin Diseases etiology, Skin Diseases immunology, Skin Diseases pathology
- Abstract
Cutaneous pseudolymphoma refers to a heterogeneous group of benign reactive T- or B-cell lymphoproliferative processes of diverse causes that simulate cutaneous lymphomas clinically and/or histologically. The inflammatory infiltrate is bandlike, nodular, or diffuse and is composed predominantly of lymphocytes with or without other inflammatory cells. Depending on the predominant cell type in the infiltrate, cutaneous pseudolymphomas are divided into T- and B-cell pseudolymphomas. Cutaneous T-cell pseudolymphomas include idiopathic cutaneous T-cell pseudolymphoma, lymphomatoid drug reactions, lymphomatoid contact dermatitis, persistent nodular arthropod-bite reactions, nodular scabies, actinic reticuloid, and lymphomatoid papulosis. Cutaneous B-cell pseudolymphomas include idiopathic lymphocytoma cutis, borrelial lymphocytoma cutis, tattoo-induced lymphocytoma cutis, post-zoster scar lymphocytoma cutis, and some persistent nodular arthropod-bite reactions. This review attempts to discuss current aspects of the classification, pathogenesis, clinical spectrum, histopathologic and immunohistochemical diagnosis, and laboratory investigations for clonality in the various types of cutaneous pseudolymphomas.
- Published
- 1998
- Full Text
- View/download PDF
41. Administration of DAB389IL-2 to patients with recalcitrant psoriasis: a double-blind, phase II multicenter trial.
- Author
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Bagel J, Garland WT, Breneman D, Holick M, Littlejohn TW, Crosby D, Faust H, Fivenson D, and Nichols J
- Subjects
- Adult, Aged, Diphtheria Toxin adverse effects, Double-Blind Method, Female, Humans, Interleukin-2 adverse effects, Male, Middle Aged, Psoriasis pathology, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins adverse effects, Diphtheria Toxin administration & dosage, Interleukin-2 administration & dosage, Psoriasis drug therapy
- Abstract
Background: Current therapies for recalcitrant psoriasis focus on immunoregulation and targeting of activated T-lymphocytes rather than keratinocytes. Previous studies with low doses of the lymphocyte-selective fusion protein DAB389IL-2 have shown benefit to patients with psoriasis., Objective: We examined the safety and efficacy of DAB389IL-2 in 41 volunteers receiving more frequent and higher doses than in a previous trial., Methods: Patients were randomized to receive either placebo or 5, 10, or 15 microg/kg daily of DAB389IL-2 intravenously for 3 consecutive days each week for 4 consecutive weeks with a subsequent 4-week observation period., Results: Of the placebo group, 17% (2 of 12) exhibited at least 50% improvement from baseline Psoriasis Area and Severity Index scores at the end of the study, whereas 24% of all treated patients (7 of 29) showed the same improvement. Overall, 3 of 12 (25%) patients given placebo as opposed to 12 of 29 (41%) patients treated with DAB389IL-2 improved to this same extent at some point during the study. The rate of improvement for treated patients was significantly greater than for placebo patients (p = 0.04; repeated measures ANOVA). Among treated patients, decreases in Psoriasis Area and Severity Index scores were paralleled by changes in the Physician's Global Assessment and the Dermatology Life Quality Index. Treatment in ten patients was discontinued because of adverse events. Flu-like symptoms were the most common with severity increasing at the two higher doses. Only one serious adverse event was reported. This occurred in a patient receiving 5 microg/kg daily who experienced vasospasm and a coagulopathy resulting in arterial thrombosis., Conclusion: Our findings are consistent with the potential antipsoriatic activity of DAB389IL-2 demonstrated in an earlier study. However, DAB389IL-2 was less well tolerated at this dosing regimen, particularly at the highest dose, and it was too toxic at these doses and schedules to be considered in the routine treatment of psoriasis.
- Published
- 1998
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42. A double-blind, multicenter clinical trial comparing efficacy of once-daily metronidazole 1 percent cream to vehicle in patients with rosacea.
- Author
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Breneman DL, Stewart D, Hevia O, Hino PD, and Drake LA
- Subjects
- Administration, Topical, Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents administration & dosage, Double-Blind Method, Female, Humans, Male, Metronidazole administration & dosage, Middle Aged, Treatment Outcome, Anti-Inflammatory Agents therapeutic use, Metronidazole therapeutic use, Rosacea drug therapy
- Abstract
The efficacy and safety of a new formulation of metronidazole 1 percent cream applied once daily was compared to vehicle cream in a double-blind, randomized, parallel group, ten-week clinical study. The results showed that metronidazole 1 percent cream was significantly better than vehicle in reducing the lesions of rosacea, improving erythema, and physician's global rosacea scores. The incidence of adverse events related to the skin was low.
- Published
- 1998
43. Calcipotriene ointment applied once a day for psoriasis: a double-blind, multicenter, placebo-controlled study.
- Author
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Pariser DM, Pariser RJ, Breneman D, Lebwohl M, Kalb R, Moore J, Moss H, Parker C, and Fiedler V
- Subjects
- Administration, Cutaneous, Adolescent, Adult, Aged, Aged, 80 and over, Calcitriol administration & dosage, Calcitriol adverse effects, Calcitriol therapeutic use, Dermatologic Agents administration & dosage, Dermatologic Agents adverse effects, Double-Blind Method, Humans, Middle Aged, Ointments, Pharmaceutical Vehicles, Placebos, Calcitriol analogs & derivatives, Dermatologic Agents therapeutic use, Psoriasis drug therapy
- Published
- 1996
44. Cetirizine versus hydroxyzine and placebo in chronic idiopathic urticaria.
- Author
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Breneman DL
- Subjects
- Adult, Chronic Disease, Double-Blind Method, Drug Tolerance, Female, Humans, Male, Placebos, Urticaria etiology, Cetirizine therapeutic use, Hydroxyzine therapeutic use, Urticaria drug therapy
- Abstract
Objective: To compare the safety and efficacy of cetirizine with that of hydroxyzine and placebo in the treatment of chronic idiopathic urticaria., Design: A 4-week multicenter, randomized, double-blind, double-dummy, placebo-controlled safety and efficacy study., Setting: Patients were treated in a variety of allergy practice settings., Patients: The study population consisted of 188 patients who were at least 12 years of age, with symptomatic chronic idiopathic urticaria that had occurred episodically for at least 6 weeks., Interventions: Patients were given either cetirizine 10 mg once daily, hydroxyzine 25 mg tid, or placebo for 4 weeks., Main Outcome Measures: Patients and investigators used a 4-point scale to evaluate symptoms of urticaria and adverse effects of treatment. Ratings were compared among those taking cetirizine, hydroxyzine, or placebo., Results: After 1 day of treatment, patients randomized to receive cetirizine 10 mg/d exhibited a reduction in the number of episodes of urticaria (and a reduction in pruritus) compared with patients who received hydroxyzine 25 mg tid and patients who received placebo (p = 0.002). The number of urticarial episodes in patients treated with hydroxyzine did not reach significance until day 2 (p = 0.001). Compared with patients who received placebo, patients who received cetirizine and those who received hydroxyzine showed reductions during weeks 1, 2, and 3 and at end-point analysis in the number and size of lesions and in the severity of pruritus (p < 0.04). Patient and physician evaluations at the end of week 4 revealed an improvement in urticarial symptoms for the hydroxyzine and cetirizine groups compared with the placebo group (p < 0.001). Four patients in the hydroxyzine group, 1 patient in the cetirizine group, and 1 patient in the placebo group discontinued the study because of sedation. No patient withdrew because of lack of efficacy., Conclusions: Cetirizine 10 mg once daily was equivalent to hydroxyzine 25 mg tid in controlling the symptoms of patients with chronic urticaria, as assessed by patient and investigator evaluations.
- Published
- 1996
- Full Text
- View/download PDF
45. A multicenter trial of calcipotriene ointment and halobetasol ointment compared with either agent alone for the treatment of psoriasis.
- Author
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Lebwohl M, Siskin SB, Epinette W, Breneman D, Funicella T, Kalb R, and Moore J
- Subjects
- Administration, Cutaneous, Adult, Calcitriol administration & dosage, Calcitriol therapeutic use, Clobetasol administration & dosage, Clobetasol therapeutic use, Dermatologic Agents administration & dosage, Drug Combinations, Female, Humans, Male, Ointments, Remission Induction, Vasoconstrictor Agents administration & dosage, Calcitriol analogs & derivatives, Clobetasol analogs & derivatives, Dermatologic Agents therapeutic use, Psoriasis drug therapy, Vasoconstrictor Agents therapeutic use
- Published
- 1996
- Full Text
- View/download PDF
46. Evaluation of cutaneous lymphomas.
- Author
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Breneman DL
- Subjects
- Biopsy, Diagnosis, Differential, Humans, Lymphoma, B-Cell classification, Lymphoma, B-Cell therapy, Lymphoma, T-Cell, Cutaneous classification, Lymphoma, T-Cell, Cutaneous therapy, Skin pathology, Skin Neoplasms classification, Skin Neoplasms therapy, Lymphoma, B-Cell diagnosis, Lymphoma, T-Cell, Cutaneous diagnosis, Skin Neoplasms diagnosis
- Published
- 1996
47. Cetirizine and astemizole therapy for chronic idiopathic urticaria: a double-blind, placebo-controlled, comparative trial.
- Author
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Breneman D, Bronsky EA, Bruce S, Kalivas JT, Klein GL, Roth HL, Tharp MD, Treger C, and Soter N
- Subjects
- Adult, Astemizole adverse effects, Astemizole pharmacokinetics, Cetirizine adverse effects, Cetirizine pharmacokinetics, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Time Factors, Astemizole administration & dosage, Cetirizine administration & dosage, Urticaria drug therapy
- Abstract
Background: Cetirizine and astemizole have been shown to be safe and effective in the treatment of patients with chronic idiopathic urticaria. Cetirizine brings about clinical benefit more rapidly., Objective: The purpose of this study was to compare the efficacy of single daily doses of cetirizine and astemizole in relieving the symptoms of chronic idiopathic urticaria, with particular emphasis on the commencement of action., Methods: Patients with chronic idiopathic urticaria were randomly assigned to relieve either 10 mg of cetirizine, 10 mg of astemizole, or placebo for 4 weeks in a multicenter double-blind trial. Patients rated symptom severity each night, and investigators rated symptoms weekly., Results: One hundred eighty-seven patients were enrolled in the trial; 180 were included in the safety analysis and 177 were included in at least one efficacy analysis. Both cetirizine and astemizole were significantly superior to placebo in relieving symptoms of chronic idiopathic urticaria. Both patients' and investigators' ratings indicated that cetirizine acted more rapidly. Both active treatments were well tolerated, and the incidence of somnolence did not differ statistically between cetirizine (14.5%) and astemizole (10.3%)., Conclusion: Both cetirizine and astemizole provide effective relief of the symptoms of chronic idiopathic urticaria with similar side-effect profiles. However, clinical benefit occurs significantly more rapidly with cetirizine.
- Published
- 1995
- Full Text
- View/download PDF
48. Nicotinamide and tetracycline therapy of bullous pemphigoid.
- Author
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Fivenson DP, Breneman DL, Rosen GB, Hersh CS, Cardone S, and Mutasim D
- Subjects
- Aged, Aged, 80 and over, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Niacinamide adverse effects, Tetracycline adverse effects, Niacinamide therapeutic use, Pemphigoid, Bullous drug therapy, Tetracycline therapeutic use
- Abstract
Background and Design: The combination of nicotinamide and tetracycline has been anecdotally reported to be effective in the treatment of bullous pemphigoid. We conducted a randomized, open-labeled trial comparing the combination of 500 mg of nicotinamide, three times daily, and 500 mg of tetracycline four times daily, with prednisone therapy in 20 patients with bullous pemphigoid. The study was divided between an 8-week acute phase with fixed drug dosages and a 10-month follow-up phase in which study medications were tapered based on patient response., Results: Eighteen of 20 patients enrolled in the study were treated, two patients were unavailable for follow-up. Twelve patients were treated with the combination of nicotinamide and tetracycline and six patients were treated with prednisone. There were five complete responses, five partial responses, one nonresponder, and one patient with disease progression in the nicotinamide and tetracycline group compared with one complete response and five partial responses in the prednisone group. There were no statistically significant differences in response parameters between the two groups. All five patients in the nicotinamide and tetracycline group receiving long-term follow-up remained disease free during medication tapering, while three patients in the prednisone group had repeated disease flare-ups with steroid tapering. Adverse effects in the nicotinamide and tetracycline group included gastrointestinal upset (two patients) and transient renal failure (one patient). In the prednisone group, there was one occurrence each of hypertension, erosive gastritis, multiple decubitus ulcers, osteomyelitis, deep venous thrombosis, and death related to sepsis. Two patients required insulin therapy for hyperglycemia., Conclusions: The combination of nicotinamide and tetracycline appears to be a useful alternative to systemic steroids in the treatment of bullous pemphigoid.
- Published
- 1994
49. Ionizing radiation therapy in dermatology.
- Author
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Goldschmidt H, Breneman JC, and Breneman DL
- Subjects
- Carcinoma, Basal Cell radiotherapy, Carcinoma, Squamous Cell radiotherapy, Female, Humans, Male, Radiation Protection, Radiotherapy methods, Radiotherapy Dosage, Skin radiation effects, Skin Diseases radiotherapy, Skin Neoplasms radiotherapy
- Abstract
The introduction of new surgical techniques and other therapeutic modalities has markedly influenced the use of ionizing radiation therapy in dermatology. X-rays and electron beams are now used only for a limited number of indications in carefully selected patients. Since surgical approaches have gained popularity in the treatment of skin tumors, not all dermatologists are familiar with the benefits of ionizing radiation for patients with cutaneous neoplasms and certain other skin disorders. This article reviews modern indications for radiation therapy in dermatology. Important physical and biologic factors, radiation side effects, radiation protection measures, and therapeutic results will also be discussed. Although the use of radiotherapy in dermatology has in large part been supplanted in recent years by other forms of treatment, ionizing radiation continues to be an essential therapeutic alternative for many cutaneous tumors and some skin diseases. It is important to be familiar with the principles of radiotherapy so that optimal therapy can be selected for individual patients.
- Published
- 1994
- Full Text
- View/download PDF
50. Cutaneous T-cell lymphoma mimicking porokeratosis of Mibelli.
- Author
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Breneman DL and Breneman JC
- Subjects
- Adult, Diagnosis, Differential, Female, Humans, Lymphoma, T-Cell, Cutaneous pathology, Porokeratosis pathology, Skin Neoplasms pathology
- Published
- 1993
- Full Text
- View/download PDF
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