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Objective: To compare the efficacy and safety between ozonated oil and compound flumethasone ointment in the treatment of psoriasis vulgaris.
 Methods: A left/right self-controlled, parallel group study was conducted. Forty patients with stable psoriasis vulgaris were enrolled in the study, whose lesions were symmetrical and involvement areas were <30% body surface. The patients were divided into 2 groups. Patients with left lesions served as a test group were treated daily for ozonated oil twice, and patients with right lesions served as a control group were treated daily for compound flumetasone ointment twice. The patients in the 2 groups were treated for 4 weeks. The clinical efficacy and safety were observed at 1, 2 and 4 weeks after the treatment.
 Results: After 1 week treatment, the effective rates of the test group and the control group were 60.58% and 72.28%, respectively, with significant difference between them (P<0.05). At 2 weeks and 4 weeks after the treatment, the efficacy in the test group was similar to that in the control group. The effective rates in the test group and the control group were 69.84% and 70.25% after 2 weeks, respectively, 70.88% and 71.23% after 4 weeks, respectively. There was no significant difference between the 2 groups (P<0.05). In addition, the reflectance confocal microscope results in both the test group and the control group after 4 weeks showed that the epidermis was approximately normal. There were few inflammatory cells infiltration in the dermal papilla, and the inflammatory cells infiltration was significantly reduced after treatment.
 Conclusion: Ozonated oil treatment for stable psoriasis is safe and effective, and its efficacy is equivalent to the effect of glucocorticoid topical preparations.

Objectives/hypothesis: The goal of this systematic review was to compare the efficacy and ototoxicity of Locacorten-Vioform (Paladin Labs Inc., Montreal, Quebec, Canada) and clotrimazole in the treatment of patients with otomycosis., Data Sources: Embase, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, World Health Organization International Clinical Trials Registry Platform, European Union Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov., Methods: We included any randomized controlled trials or nonrandomized studies (case-control, cohort, and case series) assessing the topical use of Locacorten-Vioform (Paladin Labs Inc.) and/or clotrimazole in adult and/or pediatric immunocompetent patient population with otomycosis. DerSimonian and Laird's random effects approach was used for meta-analysis, followed by an assessment of heterogeneity and subgroup analysis., Results: Of 226 reviewed articles, 14 were retained. Clotrimazole efficacy rate was 85% (95% confidence interval [CI]: 79.7-89.0%), whereas Locacorten-Vioform (Paladin Labs Inc.) was 73% (95% CI: 56.0-84.5%). Overall, study quality was low. There was high heterogeneity in both groups (I(2) of 47 and 49). There were only three studies assessing Locacorten-Vioform (Paladin Labs Inc.); therefore, comparative assessment was not possible. A one-way meta-analysis involving 13 clotrimazole studies was performed. Heterogeneity across studies was high; however, studies using objective analysis assessing treatment efficacy, randomized controlled trials, studies using drops, studies performed in Asia, and studies where Candida was the major fungus at diagnosis demonstrated low heterogeneity., Conclusion: Although both are safe and effective, there is insufficient evidence supporting increased efficacy of either clotrimazole or Locacorten-Vioform (Paladin Labs Inc.) for the treatment of otomycosis. High-quality comparative studies are required., Level of Evidence: N/A. Laryngoscope, 126:1411-1419, 2016., (© 2015 The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: To compare the clinical efficacy and safety of combining flumetasone ointment with 308-nm excimer laser therapy vs. 308-nm excimer laser monotherapy for the treatment of psoriasis vulgaris., Method: Forty patients with psoriasis vulgaris were recruited; 20 were treated with flumetasone ointment plus 308-nm excimer laser therapy, and the other 20 received only excimer laser monotherapy. The flumetasone ointment was applied topically twice a day, and laser treatments were scheduled twice weekly for a total of 10 treatments. Clinical efficacy was evaluated in a blinded manner by two independent physicians using photographs taken before and after treatment., Results: Of the 40 patients who received and completed the entire course of therapy, the psoriasis area and severity index score was improved by 82.51 ± 11.24% and 72.01 ± 20.94% in the combination group and laser group, respectively (P > 0.05), and the average cumulative dose was 5.06 ± 2.20 j/cm(2) in the combination group and 7.75 ± 2.25 j/cm(2) in the laser-only group, respectively (P < 0.05)., Conclusion: The clinical data suggest that combination treatment using flumetasone ointment and a 308-nm excimer laser is superior to laser monotherapy for treatment of psoriasis vulgaris. The combination therapy can increase effectiveness and decrease the total laser dose, thus potentially reducing side effects., (© 2012 John Wiley & Sons A/S.)

Charged drug delivery systems are interesting candidates for the delivery of drugs through skin. In the present study, it was possible to create negatively and positively charged oil/water nanoemulsions by using sucrose laureate and polysorbate 80 as non-ionic surfactants. The positively charged nanoemulsions were generated by adding cationic phytosphingosine (PS). The relationship between the physicochemical properties of the nanoemulsions was shown by particle size and zeta potential measurements. These properties were dependent on the type of non-ionic surfactant and the concentration of PS. Furthermore the cationic PS had a positive impact on the skin permeation rates (flux) of the incorporated model drugs fludrocortisone acetate and flumethasone pivalate. An enhancement factor between 1.1 and 1.5 was obtained in relation to the control. The interaction of pre-impregnated porcine skin with positively and negatively charged nanoemulsions was confirmed by DSC analysis. The generated DSC-curves showed a slight difference in the phase transition temperature assigned to the characteristic lipid transition. However, it was not possible to assign the effect to one of the ingredients in the multicomponent system.

Clinicians often prescribe otic drops anecdotally to try and clear grommets blocked with blood. We carried out an in vitro double-blind randomized controlled study comparing the efficacy of sodium bicarbonate, Locorten Vioform and olive oil drops in clearing Shah grommets placed in 'artificial ears' and blocked with blood in a standardized fashion. There were 33 grommets in each group, and drops were inserted three times a day for 7 days. Olive oil drops cleared 17 of 33 (51.51%), Locorten Vioform cleared one of 33 (3%) and sodium bicarbonate cleared zero of 33 (0%) blocked grommets. Statistical comparison between pairs indicates that olive oil was significantly better than both Locorten Vioform (P < 0.001) and sodium bicarbonate drops (P < 0.001) at clearing grommets blocked with blood.

A field study was performed to assess the drug residue level in edible tissues after a therapeutic application of the synthetic glucocorticoids dexamethasone and flumethasone. Three diseased calves were injected intramuscularly with a commercial batch of dexamethasone esters and slaughtered 72 h after treatment. Another three calves were injected intramuscularly with an aqueous flumethasone preparation and slaughtered 24 h later. Residues of synthetic glucocorticoids in liver, muscle, kidney, and urine were assessed by competitive enzyme immunoassay. All dexamethasone concentrations exceeded the maximal residue level of 0.75 microg/kg in muscle and kidney and 2 microg/kg in the liver. The presence of both dexamethasone and flumethasone in the liver was confirmed by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). These results indicate that liver tissue provides a suitable matrix to monitor the presence of illegal residues of synthetic glucocorticoids in slaughtered animals.

Objective: To investigate effects of preterm induction of calving by administration of flumethasone and dinoprost on the lecithin-to-sphingomyelin ratio in amniotic fluid and on neonatal respiratory distress after birth., Animals: 45 dairy cows and their newborn calves., Procedure: Amniotic fluid from 45 cows was obtained and tested between days 258 and 270 of gestation. Cows were then given flumethasone (10 mg; n = 15), dinoprost (25 mg; n = 15), or saline solution (n = 15). Thirty hours later, left flank cesarean section was performed, amniotic fluid was collected, and the calf was delivered. Blood for determination of progesterone was withdrawn at amniotic fluid sample collections and before induction of calving. Blood for analysis of pH and base deficit was collected from calves during cesarean section and repeatedly after birth. Phospholipids in amniotic fluid were measured by thin-layer chromatography, and progesterone was determined by radioimmunoassay. Base deficit and pH were measured, using a blood gas analyzer., Results: Before treatments, a corpus luteum was present in all cows and the lecithin-to-sphingomyelin ratio in amniotic fluid did not differ between groups. Thirty hours after injections of flumethasone and dinoprost, progesterone concentration had decreased (P < 0.05) and the lecithin-to-sphingomyelin ratio was significantly (P < 0.05) higher than values in controls. In calves delivered after flumethasone or dinoprost treatments, the degree of acidosis was significantly (P < 0.05) less than that in controls., Conclusions: Flumethasone and dinoprost, given to pregnant cows, accelerate fetal lung maturation and improve respiratory function after birth.

Objective: To compare relative efficacy of dexamethasone and flumethasone alone or in combination with rapid IV infusion of glucose for treatment of ketosis in cattle., Design: Clinical trial., Animals: 127 cows with urine acetoacetate concentration > or = 60 mg/dl., Procedure: Cows were treated with 500 ml of 50% glucose solution. IV, and 40 mg of dexamethasone, IM (group 1), 40 mg of dexamethasone, IM (group 2), 5 mg of flumethasone (group 3), or 500 ml of 50% glucose solution, IV, and 5 mg of flumethasone (group 4). Treatment success was defined as recovery after a single treatment without relapse during the same lactation. Uterine disease (retained placenta or metritis), parity, and pretreatment plasma glucose, serum beta-hydroxybutyric acid, and urine acetoacetate concentrations were evaluated as possible confounding factors affecting recovery., Results: Only uterine disease was found to have a significant effect on recovery. Treatments 1 and 4 were significantly more efficacious than was treatment 2, but efficacy of treatment 2 was not significantly different from that of treatment 3. Regardless of treatment, cows with uterine disease were less likely to have a successful outcome than were cows without uterine disease. In all treatment groups, plasma glucose concentration increased and serum beta-hydroxybutyric acid and urine acetoacetate concentrations decreased following treatment., Clinical Implications: In this study, treatment of ketosis in dairy cattle with a corticosteriod alone was less efficacious than treatment with glucose and a corticosteroid.

Little is known about patient compliance with topical aural antibiotic regimens. The compliance of 50 patients with unilateral otitis externa attending an otolaryngology clinic was studied by comparing the weight of dispensed topical ear preparations before and after completion of a 7-day-course of treatment. A standard was obtained from controlled administration of the preparation under laboratory conditions and the performance of different delivery systems evaluated. Thirty-seven patients re-attended for review with their medication. A total of 34 of 50 patients entering the study (70%) satisfied conventional criteria for compliance. However, over-use of preparations was common and stricter criteria are proposed and applied. Compliance was significantly increased when someone other than the patient administered the preparation.

Two therapeutic regimens for seborrheic dermatitis in infancy were compared. Fifteen infants were treated with topical glucocorticosteroid (flumethasone pivalate 0.02 percent) and fifteen with aqueous solution of the staining agent eosin 2 percent. Following two days of treatment a similar degree of healing was noted in both groups, and after ten days almost complete healing of the lesions was observed in all of the infants.

Effects of intramammary infusion of prednisolone (40 mg) or intramuscular injection of dexamethasone (30 mg) or flumethasone (5 mg) on local and systemic signs in Escherichia coli endotoxin-induced mastitis were studied. The effect of varying intervals (0, 2, and 4 h) between intramammary infusion of endotoxin and prednisolone in the same quarter was determined. Intramammary infusion of endotoxin (.01 mg lipopolysaccharide of E. coli) produced inflammation of the infused quarter, fever, tachycardia, and leukopenia followed by a neutrophilic leukocytosis in the blood and a decrease in plasma zinc and iron concentrations. All corticosteroid treatments, except intramammary administration of prednisolone 4 h after endotoxin infusion, enhanced leukocytosis and diminished local signs of inflammation. Intramuscular injection of dexamethasone or flumethasone together with intramammary infusion of endotoxin and intramammary administration of prednisolone 2 h after lipopolysaccharide infusion completely abolished the febrile response. Abolishment of fever and attenuation of several hematologic and blood biochemical changes may be explained by diminished synthesis of endogenous mediators within the inflamed quarters due to glucocorticosteroid action.

In this in-patient study, mild skin atrophy was observed clinically in 6 out of a total of 22 patients after fluocinolone acetonide and in one patient after flumethasone pivalate ointment applications (P less than 0,05). Investigations were discontinued prematurely on days 14 and 17 in 2 patients because they developed early atrophy due to fluocinolone acetonide applications. Histological findings indicating either moderate or marked skin atrophy were evident in 15 patients after flucinolone acetonide as against one patient after flumethasone pivalate ointment applications (P less than 0.001). In comparison with the controls the mean decrease in epidermal thickness was more marked after fluocinolone acetonide applications, namely 30.5% vs 21.3% after flumethasone pivalate applications. The ultrastructural tissue changes were less marked at the sites to which flumethasone pivalate was applied. In comparison with controls, the percentages of mean decrease in diameters of collagen fibrils measured in six volunteer patients ranged from 5.1% to 27.6% after fluocinolone acetonide and from 0% to 12.3% following flumethasone pivalate ointment applications, This difference was statistically significant (range P less than 0,01 to less than 0.001). This experimental study has demonstrated that flumethasone pivalate displays only a mild atrophogenic effect and it is clinically and histologically significantly less atrophogenic than fluocinolone acetonide. Flumethasone pivalate can therefore be reckoned as a suitable topical corticosteroid especially for the long-term treatment of corticoid-responsive dermatoses.

A double-blind randomized evaluation of betamethasone dipropionate cream (Diprosone) compared with Locacorten 0.02% cream flumethason privalate in 60 patients over 3 consecutive weeks showed the betamethasone dipropionate cream to be significantly more effective in the treatment of psoriasis and other steroid-responsive dermatoses.

In a double-blind study involving 430 patients, Locacorten (0.02%)-Vioform (3%) cream was found to be highly effective in the treatment of dermatological conditions complicated by secondary bacterial involvement. Themicrobiological conversion and clinical improvement in patients treated with Locacorten-Vioform combinations were markedly greater than those achieved in the groups medicated with (1) Vioform 3%, (2) Locacorten 0.02%, and (3) placebo cream. Staphylococcus aureus was the most prevalent organism isolated from the skin lesions. All strains were sensitive to Vioform, as compared to 62% found to be resistant to other antimicrobials.

The acute contra-inflammatory effects of salicylic acid, three standard dermatocorticoids and four contact antiphlogistics have been investigated by means of a UV dermatitis inhibition test in the guinea pig. The substances tested had a distinct inhibitory effect on the development of erythema and can be ranked in the following ascending order of activity (percent of maximum possible score): bufexamac = 36%, salicylic acid = 37%, hydrocortisone = 44%, acetylsalicylic acid = 48%, flumethasone pivalate = 51%, fluocinolone acetonide = 51%, phenylbutazone = 56%, and indomethacin = 58%.

The combination of 0.02% flumetasone pivalate and 1% salicylic acid in a water-alcohol solution (Locasalen) is a novel therapeutic for topical treatment of the hairy scalp and also for the cosmetically acceptable treatment of other skin areas, that is, exposed skin. An investigation was carried out in 6 patients with psoriasis capitis and 6 control subjects in order to determine whether the use of Locasalen Tincture on the hairy scalp leads to percutaneous absorption of the corticosteroid and the salicylic acid. In the patients with psoriasis a few slight transient changes in biochemical-endocrinological parameters were observed, but not in the control subjects. However, these changes remained within the normal, non-pathological range so that they are of no clinical consequence. Percutaneous absorption of salicylic acid was not observed in either patient group.

In human volunteers presenting with normal skin an investigation has been carried out to determine the specific skin surface dose, the actual application volume, and the theoretical surface film thickness resulting from thin and thick layer inunction of 4 common corticosteroid topicals. The findings obtained indicate that the skin surface dose provides the most suitable criterion for the terrain saturation behaviour exhibited by different formulation types of semi-solid topical preparations (inunguenda). Various aspects of the surface dosage concept are discussed with regard to the active agents and forms of application of external skin remedies. Predicative clinical determinations of the skin surface doses of topicals relating to special therapeutic and assessment procedures are believed to be a valuable complement to experimental (predictive) determinations of this parameter; some problems involved are pointed out by reference to a clinical trial example. Data on the application dosage of topicals--either by skin surface dose or by volume or layer thickness quantification--have been extracted from the dermatological literature and are reviewed with the aim of furnishing a basis for comparative estimation of our experimental results.

The risk of systemic effects of high doses of potent topical corticosteroids was evaluated in 6 psoriatics with lesions on more than 50% of the body surface. Before the examinations the patients had been treated for 3-4 months with 35-65 g fluorinated corticosteroids daily. General clinical examination, plasma cortisol determinations, and tetracosactrin tests were carried out. One patient showed clinical signs of Cushing's syndrome including diabetes mellitus, another had a slight Cushingoid appearance. The plasma cortisol levels were depressed in 5 of the 6 patients on the first post-treatment day. A subnormal plasmacortisol response to tetracosactrin stimulation was noted in 3 of the patients. In these cases the potent corticosteroid therapy was discontinued. One month later a follow-up was performed, which showed a clinical and laboratory normalization except for the tetracosactrin test in one case. The study emphasizes the risk of serious systemic effects of the absorbed corticosteroids, if high doses are used for long periods.

We report the results of a controlled double blind assay of treatment in 51 dermatologic cases, with a new steroid cream (diflucortolone) and an already known one (flumetasone). The diflucortolone valerate was significantly better than the flumetasone pivalate in the treatment of 16 cases of psoriasis, 33 eczemas and two cases of lichên planus.

Double blind study with contralateral comparison, between diflucortolon valerianat, 0.1% and the flumetason pivalat, 0.02% in pomades (ointments). Selection of 52 patients both sexes and variable ages with bilateral dermatological inflamatory lesions and with simetric preference: Psoriasis, "eczema vario" and neurodermatitis. In psoriasis, diflucortolon offered better results: the same occurred in the cases of eczema, and in neurodermatitis. The efficacy was similar. There were no appearances of negative secondary effects because of the used doses and time.

The combination creams, betamethasone dipropionate/clotrimazole/gentamicin sulphate and flumethasone pivalate/clioquinol, were compared in patients with corticosteroid responsive dermatoses and/or cutaneous fungal and/or bacterial infections. Medication was applied to affected areas twice daily for 28 days. Of 67 patients enrolled, 31 treated with betamethasone/clotrimazole/gentamicin and 33 given flumethasone pivalate/clioquinol were evaluated for efficacy and safety each week during therapy and once 14 days post-therapy. Disease signs and symptoms were less severe in the group given betamethasone/clotrimazole/gentamicin than in the comparative group at days 7 (P = 0.04), 21 (P = 0.02), 28 (P = 0.09), and 42 (P = 0.09) and at patients' last valid visit (P = 0.06). By the last valid visit, signs/symptoms had improved by 82% for patients treated with betamethasone/clotrimazole/gentamicin versus 68% for those treated with flumethasone pivalate/clioquinol. Patients given betamethasone/clotrimazole/gentamicin had statistically significantly better therapeutic responses than those given flumethasone pivalate/clioquinol at day 7 and, by the last valid visit, 19/31 (61%) patients given betamethasone/clotrimazole/gentamicin compared to 15/33 (45%) given flumethasone pivalate/clioquinol had a complete cure or an excellent therapeutic response. Median time of onset of relief of erythema and pruritus was approximately 2 days, regardless of treatment. No adverse reactions were reported.