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Background: Clascoterone cream 1% is a topical androgen receptor inhibitor approved to treat acne vulgaris in patients =>12 years of age. This report provides details of patients who developed laboratory signs of hypothalamic-pituitary-adrenal (HPA) axis suppression without clinical signs of adrenal suppression during the clascoterone development program., Methods: Two open-label, multicenter, Phase 2 trials evaluated HPA axis suppression in patients with moderate-to-severe acne vulgaris. Study 1 (NCT01831960) enrolled cohorts of adults =>18 years of age and adolescents =>12 to <18 years of age. Study 2 (NCT02720627) enrolled adolescents 9 to <12 years of age. Patients applied clascoterone twice daily at maximum-exposure dosages for 14 days. Adrenal suppression was evaluated via cosyntropin stimulation test (CST) at baseline and day 14. Patients with an abnormal CST result (serum cortisol level =<18 µg/dL) had a follow-up CST approximately 4 weeks later. Blood was collected for pharmacokinetic analysis. Other safety assessments included adverse events (AEs), physical examination/vital signs, and electrocardiography., Results: Overall, 5/69 clascoterone-treated patients had an abnormal CST result on day 14, including 1/20 adults, 2/22 patients aged =>12 to <18 years, and 2/27 patients aged 9 to <12 years. All patients had normal cortisol levels at follow-up testing approximately 4 weeks later. No relationship was observed between abnormal CST results and clascoterone plasma concentrations or the amount of study drug applied. No clinically relevant AEs or clinically significant changes in safety measures were observed in patients with adrenal suppression., Conclusion: Clascoterone induced laboratory evidence of mild, reversible HPA axis suppression under maximum-use exposure. J Drugs Dermatol. 2024;23(6):433-437.     doi:10.36849/JDD.7997.

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination approved for the treatment of acne. This post hoc analysis investigated the efficacy and safety of CAB in pediatric (<18 years) and adult (greater than or equal to 18 years) participants., Methods: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants greater than or equal to 9 years of age with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed for pediatric and adult subpopulations. Assessments included treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear], inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability., Results: At week 12, treatment success rates for both pediatric and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P<0.01, both). CAB-treated participants in both subgroups experienced greater reductions from baseline versus vehicle in inflammatory (pediatric: 78.6% vs 50.4%; adult: 76.6% vs 62.8%; P<0.001, both) and noninflammatory lesions (pediatric: 73.8% vs 41.1%; adult: 70.7% vs 52.2%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than with a vehicle. Most TEAEs were of mild-to-moderate severity; no age-related trends for safety/tolerability were observed.  Conclusions: CAB gel demonstrated comparable efficacy, quality of life improvements, and safety in pediatric and adult participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment option for patients with acne. J Drugs Dermatol. 2024;23(6):394-402.     doi:10.36849/JDD.8357.

Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported., Methods: In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator's Global Assessment scores (IGA 0/1) in patients aged 12 years or older in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study., Results: Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment., Conclusions: The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged 12 years or older with acne vulgaris.   J Drugs Dermatol. 2024;23(1):1278-1283.     doi:10.36849/JDD.7719.

Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented.  Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually.  Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end., Conclusions: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.

Background/objectives: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne., Methods: In a randomized, double-blind phase 2 study (NCT03170388), participants ≥9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability., Results: At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%; p < .001) or any of the dyad combinations (range: 30.8%-33.9%; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; p < .001, both) and 9.2%-16.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity., Conclusion: IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne., (© 2023 The Authors. Pediatric Dermatology published by Wiley Periodicals LLC.)

Importance: Acne vulgaris is an inflammatory disease of the pilosebaceous unit of the skin that primarily involves the face and trunk and affects approximately 9% of the population worldwide (approximately 85% of individuals aged 12-24 years, and approximately 50% of patients aged 20-29 years). Acne vulgaris can cause permanent physical scarring, negatively affect quality of life and self-image, and has been associated with increased rates of anxiety, depression, and suicidal ideation., Observations: Acne vulgaris is classified based on patient age, lesion morphology (comedonal, inflammatory, mixed, nodulocystic), distribution (location on face, trunk, or both), and severity (extent, presence or absence of scarring, postinflammatory erythema, or hyperpigmentation). Although most acne does not require specific medical evaluation, medical workup is sometimes warranted. Topical therapies such as retinoids (eg, tretinoin, adapalene), benzoyl peroxide, azelaic acid, and/or combinations of topical agents are first-line treatments. When prescribed as a single therapy in a randomized trial of 207 patients, treatment with tretinoin 0.025% gel reduced acne lesion counts at 12 weeks by 63% compared with baseline. Combinations of topical agents with systemic agents (oral antibiotics such as doxycycline and minocycline, hormonal therapies such as combination oral contraception [COC] or spironolactone, or isotretinoin) are recommended for more severe disease. In a meta-analysis of 32 randomized clinical trials, COC was associated with reductions in inflammatory lesions by 62%, placebo was associated with a 26% reduction, and oral antibiotics were associated with a 58% reduction at 6-month follow-up. Isotretinoin is approved by the US Food and Drug Administration for treating severe recalcitrant nodular acne but is often used to treat resistant or persistent moderate to severe acne, as well as acne that produces scarring or significant psychosocial distress., Conclusions and Relevance: Acne vulgaris affects approximately 9% of the population worldwide and approximately 85% of those aged 12 to 24 years. First-line therapies are topical retinoids, benzoyl peroxide, azelaic acid, or combinations of topicals. For more severe disease, oral antibiotics such as doxycycline or minocycline, hormonal therapies such as combination oral conceptive agents or spironolactone, or isotretinoin are most effective.

Background: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne., Methods: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (&ge;2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed., Results: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P&lt;0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P&lt;0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups., Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959.

Background: Acne vulgaris (acne) is a common skin condition in children and adolescents. Efficacy of tretinoin is well documented in studies that included pediatric patients (12-18 years of age). With acne routinely presenting in younger patients, data are needed in this important group. Lotion formulations are commonly used across dermatology and are well liked by patients., Objective: To evaluate the safety and efficacy of a novel once-daily tretinoin 0.05% lotion in preadolescent subjects (≤ 13 years) with moderate-to-severe acne., Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-to-severe acne. Preadolescent subjects (N = 154) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability evaluated throughout., Results: At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% compared with 31.4% and 18.8% with vehicle (both P = 0.001). Treatment success was achieved by 23.7% of subjects by Week 12, compared with 7.2% (P = 0.009). The majority of AEs were mild and transient: most frequently were application site pain (5.6%) and application site dryness (2.8%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by Week 12., Conclusions: Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It was well tolerated, with all treatment-related AEs deemed mild or moderate., (© 2019 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)

Background/objectives: The pathogenesis of preadolescent acne has not been well studied, and it is uncertain if Cutibacterium acnes is a predominant organism in the microbiome in this age group. The aim of this study was to analyze the microbiome of preadolescent females and to assess whether benzoyl peroxide impacts the microbiome., Methods: The study enrolled girls, aged 7-12 years, with evidence of at least six acne lesions who had not been previously treated. Participants' skin surface of forehead, cheeks, nose, chin, left retroauricular crease, and extruded contents of a comedonal lesion were sampled at baseline. Participants used benzoyl peroxide 4% wash for 6-8 weeks and returned for skin surface sampling and extraction collection. Microbiome analysis was performed using 16S ribosomal RNA gene amplicon sequencing on all swab and lesional extraction samples., Results: Fifty-one participants were enrolled with a median IGA score of 2 (mild). Changes in microbiome diversity were associated with increasing age and number of acne lesions (P = 0.001). C. acnes had higher abundances on forehead and nose, as opposed to cheeks and chin (P = 0.009). Bacterial diversity (alpha diversity) of the skin microbiome was comparable between preadolescent at baseline and after treatment with benzoyl peroxide., Conclusion: This is the first large assessment characterizing female acne microbiome in early and late preadolescence. Results show that preadolescent acne can vary in its microbial profile, reflecting surrounding changes associated with the onset of puberty. Although benzoyl peroxide use was associated with decreased acne counts, its effect on microbial diversity was not demonstrated in our study., (© 2019 Wiley Periodicals, Inc.)

Background: Acne fulminans (AF) is a severe variant of inflammatory acne. It typically manifests as an explosive worsening and ulceration of skin lesions, and can be associated with systemic symptoms. However, there is a paucity of evidence-based information and no clear guidelines concerning the classification and treatment of AF., Objective: To better define the spectrum of AF and its variants, devise optimal therapeutic approaches, and identify areas of future research., Methods: A panel of physicians with expertise in severe acne vulgaris was convened after a comprehensive literature review of severe acne variants. Priority topics were reviewed and presented by each panelist at a 5-hour conference. Following review of the audiotape and scribed notes from the conference, surveys were utilized to address points of controversy and to clarify consensus recommendations., Results: Appropriate clinical case presentations and consensus survey questions were utilized to create final recommendations based on both the literature and the expert consensus., Limitations: Limited evidenced-based data and prospective studies in the literature concerning the treatment of AF is available., Conclusion: These guidelines better characterize AF and provide health care practitioners approaches to the classification, treatment, and prevention of AF and its variants., (Copyright © 2016 American Academy of Dermatology, Inc. All rights reserved.)

Objective: This randomized, double-blind, placebo-controlled, Phase 2 study compared efficacy, tolerability, and safety of SB204 once or twice daily to vehicle in the treatment of acne vulgaris., Methods: Eligible subjects were to be between 12 and 40 years old, have facial acne vulgaris with 25 to 70 non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, and a baseline Investigator's Global Assessment (IGA) score of moderate or severe. The co-primary efficacy endpoints were the absolute change in inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to week 12). Safety assessments included reported adverse events (AEs), physical examinations, and laboratory testing. Tolerability was evaluated by the investigators based on the occurrence and severity of erythema, scaling, dryness, pruritus, and burning/stinging., Results: A total of 213 subjects were randomized: 27 subjects to vehicle once daily; 29 subjects to vehicle twice daily; 53 subjects to SB204 2% twice daily; 52 subjects to SB204 4% once daily; and 52 subjects to SB204 4% twice daily. When compared to vehicle, treatment with all 3 SB204 regimens significantly reduced the absolute inflammatory lesion count and SB204 4% once daily reduced the absolute non-inflammatory lesion count. Treatment with SB204 4% once daily demonstrated a significant reduction in percent inflammatory lesions by week 4. There were no significant differences in the IGA success rates between groups at the end of treatment. All treatment regimens of SB204 were found to be safe and well tolerated., Conclusions: When compared to vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory lesion count and SB204 4% once daily also significantly decreased the absolute non-inflammatory lesion count in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated. J Drugs Dermatol. 2016;15(12):1496-1502.

Purpose: Studies have documented practice gaps in acne management between pediatricians and dermatologists. Evidence-based recommendations for acne management were published by the American Acne and Rosacea Society and the American Academy of Pediatrics in 2013. We assess the impact of a case-based learning intervention on pediatrician knowledge and treatment of acne in accordance with published recommendations., Methods: Participants were recruited at four conferences for pediatric providers. Knowledge of the recommendations and confidence in utilizing them was assessed. Five case-based questions were presented, with providers choosing acne treatments before, immediately after, and 3 months after a case-based educational presentation. Answer selections consistent with the recommendations were scored as correct, and all responses were evaluated for patterns of medication selection., Results: A total of 150 individuals participated, most with over 10 years experience. Knowledge of the recommendations and confidence in prescribing acne therapy was poor. The average preintervention management selections were 70% correct, increasing significantly to 86% 3 months after intervention (p < .01). The most significant improvements were demonstrated in provider's ability to choose regimens for moderate acne consistent with published recommendations, and in recommendation-consistent usage of retinoids and benzoyl peroxide (p < .05). Persisting practice gaps included a reluctance to use topical retinoids in preadolescents and lack of initiating oral combination therapies in patients with severe acne., Conclusions: A case-based educational intervention significantly increased providers choosing acne treatments in accordance with evidence-based recommendations in an examination setting. Limitations of the study include an inability to assess actual provider prescribing behavior through this methodology., (Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Dapsone gel, 5% is administered twice daily for the treatment of acne vulgaris, and some patients may find adherence challenging.
, Objective: The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.
, Methods: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20-50 facial inflammatory lesions, 30-100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
, Results: The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P&lt;0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P&lt;0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from "none" to "mild."
, Conclusion: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.

J Drugs Dermatol. 2016;15(8):962-969.

Introduction: Although hormonal contraceptives may help acne or worsen it, there is limited evidence on the effects of many commonly prescribed agents. The present study evaluates patient-reported effect on acne from 2147 patients who were utilizing a hormonal contraceptive at the time of their initial consultation for acne.
, Methods: At the time of initial consultation for acne, each of 2147 consecutive patients using hormonal contraception provided her assessment of how her contraceptive had affected her acne. The Kruskal-Wallis test and logistic regression analysis were used to compare patient-reported outcomes by contraceptive type.
, Results: Depot injections, subdermal implants, and hormonal intrauterine devices worsened acne on average, and were inferior to the vaginal ring and combined oral contraceptives (COCs; P &le; .001 for all pairwise comparisons), which improved acne on average. Within COC categories, a hierarchy emerged based on the progestin component, where drospirenone (most helpful) &gt; norgestimate and desogestrel &gt; levonorgestrel and norethindrone (P &le; .035 for all pairwise comparisons). The presence of triphasic progestin dosage in COCs had a positive effect (P = .005), while variation in estrogen dose did not have a significant effect (P = .880).
, Conclusions: Different hormonal contraceptives have significantly varied effects on acne, including among types of COC.

J Drugs Dermatol. 2016;15(6):670-674.

In part 1 of this 3-part series, an overview of the epidemiology, visible patterns, and important considerations for clinical and laboratory evaluation of acne vulgaris (AV) in adult women was provided. Proper selection and integration of skin care products is important in the management of AV in this patient population. Part 2 of this series includes a discussion of over-the-counter and prescription topical therapies for adult women with AV. A summary of key randomized controlled trials also is provided. Further well-designed studies are needed, as data on the use of topical agents in this subpopulation are limited.

Acne presenting in adult women is commonly encountered in clinical practice. Many affected women have had acne during their teenaged years, have tried several therapies in the past, and are seeking effective treatment. Others are frustrated by the inexplicable emergence of acne as an adult when they never had it as a teenager. Both groups seek an explanation of why they have acne, are often psychosocially affected by its effects on appearance and self-esteem, and all are wanting effective and safe treatment. Clinicians are encouraged to connect favorably with each patient through careful history and physical examination and to consider underlying causes of androgen excess. Practical approaches to examination and laboratory evaluation are discussed.

As the pathophysiology of acne is complex and multifactorial, the continued influx of new basic science and clinical information requires careful analysis before drawing conclusions about what truly contributes to the development and progression of this chronic disease. Our objective is to review the latest evidence and highlight a number of important perspectives on the pathophysiology of acne. An improved understanding of acne pathogenesis should lead to more rational therapy and a better understanding of the role of P acnes opens new perspectives for the development of new treatments and management. Further research may be directed at targeting receptors, adhesion molecules, cytokines, chemokines or other pro-inflammatory targets implicated in the activation of immune detection and response (i.e., toll-like receptors [TLRs], protease-activated receptors [PARs]) that appear to contribute to the pathophysiology of acne. Therapeutic options that reduce the need for topical and/or oral antibiotic therapy for acne are welcome as bacterial resistance to antibiotics is a clinically relevant concern both in the United States and globally.

Objective: Evaluate the efficacy and safety of adapalene 0.1%-benzoyl peroxide 2.5% gel (adapalene-BPO) in patients 9-11 years old with acne vulgaris.
, Methods: Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale. Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate (percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory and non-inflammatory lesion counts at each visit, the Children's Dermatology Life Quality Index (C DLQI) at baseline and week 12, and the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].
, Results: A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001). More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child's acne significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).
, Conclusions: In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction compared to vehicle.

Introduction: Acne vulgaris is one of the most common skin conditions in children and adolescents. The presentation, differential diagnosis, and association of acne with systemic pathology differs by age of presentation. Current acknowledged guidelines for the diagnosis and management of pediatric acne are lacking, and there are variations in management across the spectrum of primary and specialty care. The American Acne and Rosacea Society convened a panel of pediatric dermatologists, pediatricians, and dermatologists with expertise in acne to develop recommendations for the management of pediatric acne and evidence-based treatment algorithms., Methods: Ten major topic areas in the diagnosis and treatment of pediatric acne were identified. A thorough literature search was performed and articles identified, reviewed, and assessed for evidence grading. Each topic area was assigned to 2 expert reviewers who developed and presented summaries and recommendations for critique and editing. Furthermore, the Strength of Recommendation Taxonomy, including ratings for the strength of recommendation for a body of evidence, was used throughout for the consensus recommendations for the evaluation and management of pediatric acne. Practical evidence-based treatment algorithms also were developed., Results: Recommendations were put forth regarding the classification, diagnosis, evaluation, and management of pediatric acne, based on age and pubertal status. Treatment considerations include the use of over-the-counter products, topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, and isotretinoin. Simplified treatment algorithms and recommendations are presented in detail for adolescent, preadolescent, infantile, and neonatal acne. Other considerations, including psychosocial effects of acne, adherence to treatment regimens, and the role of diet and acne, also are discussed., Conclusions: These expert recommendations by the American Acne and Rosacea Society as reviewed and endorsed by the American Academy of Pediatrics constitute the first detailed, evidence-based clinical guidelines for the management of pediatric acne including issues of special concern when treating pediatric patients.

Although acne vulgaris is common in preadolescents (<13 yrs), few acne treatments are currently approved for children. This study assessed the safety and efficacy of tretinoin microsphere gel (TMG) 0.04% pump in children aged 9-11 with acne vulgaris. In this multicenter, randomized, double-blind, vehicle-controlled pilot study, patients applied TMG 0.04% pump or vehicle once daily to the face for 12 weeks. Efficacy measures were changes in facial lesion counts, Investigator Global Evaluation of acne severity using two scales, and Investigator Global Assessment of Improvement from baseline to week 12. Of the 110 patients enrolled, 55 received TMG 0.04% pump, and 55 received vehicle. At week 12, there was significantly greater improvement in the least-squares mean change in noninflammatory lesions with TMG 0.04% than with vehicle (-19.9 vs -9.7, p = 0.04) and a significant difference in Investigator Global Assessment of improvement at week 12 between the children treated with TMG 0.04% pump and those treated with vehicle (p = 0.02), but there were no discernible differences in static acne severity scales. Change from baseline in signs and symptoms of cutaneous irritation were similar between the active and vehicle arms at week 12. This study demonstrated statistically significant differences in the reduction of noninflammatory lesions between TMG 0.04% pump and vehicle in patients aged 9-11 with acne vulgaris. Additional studies are warranted to further characterize the safety and efficacy of TMG 0.04% pump for the treatment of acne in the preadolescent population., (© 2012 Wiley Periodicals, Inc.)

Objective: Acne is common in adolescents and especially difficult to manage in people with color. A fixed combination of clindamycin phosphate and benzoyl peroxide (BPO) (clindamycin phosphate 1.2%/BPO 2.5% gel) was evaluated to determine its utility in treating moderate to severe acne in adolescents with skin of color., Methods: Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects., Results: Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile., Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.

Background: Topical fixed-combination therapy containing 1% clindamycin as 1.2% clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective treatment for acne vulgaris (acne)., Objectives: To demonstrate that the combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and vehicle gel., Methods: A total of 1,319 patients with acne, aged 12 years or older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy was evaluated using a six-point Investigator's Static Global Assessment (ISGA) and Subject's Global Assessment (SGA) of acne severity and lesion counts (inflammatory, non-inflammatory, and total). Safety assessments included skin tolerability and adverse events (AEs)., Results: A greater proportion of subjects who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% and vehicle alone in the absolute reduction from baseline to week 12 in all three lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior to BPO 3% alone in the absolute reduction from baseline to week 12 in inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of product-related AEs was low and similar in all study groups (1% with CLNP 1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local tolerability assessments showed similar minimal changes from baseline to week 12 in all study groups., Conclusion: CLNP 1.2%-BPO 3% gel provides superior efficacy to improve ISGA score and reduce inflammatory and total lesion counts compared with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while maintaining a highly favorable safety and tolerability profile similar to BPO 3% alone.

The effective and safe treatment of acne vulgaris often is affected by individual patient characteristics, including skin color and cultural background. Skin of color is especially prone to hyperpigmentation, both from lesions and from irritating therapy. Clinicians also should be aware of cultural attitudes and folk remedies that may adversely affect dermatologic conditions such as acne., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Acne is no longer simply a diagnosis based on the appearance of characteristic lesions on the skin of adolescents. The presentation of acne differs across age groups, and the population of younger pediatric patients with acne continues to grow. This article addresses the changing epidemiology and demographics of acne, with specific emphasis on the 7- to 11-year-old acne patient population; the differences and similarities between pediatric acne and adolescent acne; age-based acne epidemiology; and current perspectives on acne etiology., (Copyright © 2011 Elsevier Inc. All rights reserved.)

By late adolescence, almost all individuals have experienced some degree of acne. A broad range of acne treatments has been shown to be safe and effective in adults. While still sparse, emerging data now also document similar safety and efficacy of these agents for children >12 years of age. For younger children with preadolescent acne, where data are more limited or unavailable, it seems reasonable to extrapolate from the findings of studies involving older children >12 years of age. This article reviews the latest evidence and current expert opinions on acne therapies in the pediatric age group., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Acne vulgaris is classically considered a disease of adolescence. Although it most commonly occurs and has been best studied in that age group, it can develop at any time during childhood. It is important that health care practitioners recognize the manifestations of neonatal, infantile and childhood acne, as well as the differential diagnosis and best therapeutic approach in the younger child. Acneiform eruptions in infants and toddlers can occasionally be associated with scarring or with other significant disorders that may be life-threatening. In this article, the authors draw on their own clinical experience as well as the available literature to suggest an age-based approach to managing acne in children from the neonatal period through age 11 years., (Copyright © 2011. Published by Elsevier Inc.)

Background: Assessment of adverse effects in pediatric patients on oral isotretinoin has not been standardized and the exact incidence is unknown., Objective: Our goal was to determine the usefulness of an isotretinoin symptom survey as a screening tool for assessment and quantification of adverse effects, including psychiatric symptoms, during isotretinoin treatment in a pediatric population of different age groups., Methods: We performed a retrospective chart review on a random sample of patients treated with isotretinoin at a tertiary pediatric dermatology clinic where patients completed an isotretinoin symptom survey at each visit. Responses were stratified by age group and psychiatric history., Results: The charts of 102 patients, representing 123 courses of isotretinoin and 760 treatment-months, were reviewed. A total of 722 (95.0%) symptom surveys were complete and 38 (5.0%) were incomplete/missing. Recorded side effects were similar to published adult data; dry lips/dry skin were reported in 94.25% and 72.13% of treatment-months of isotretinoin, respectively. Psychiatric symptoms were reported in 1.65%, with no statistical difference between patients with or without a mental health history. Patients aged 11 to 15 years had similar side-effect profiles to those aged 16 to 21 years. Impaired night vision, nosebleeds, and dry/bloodshot eyes were more common in the older age group., Limitations: This was a retrospective chart review, with known limitations. The study was performed at a tertiary referral center for pediatric dermatology, possibly allowing patient selection bias., Conclusions: The isotretinoin symptom survey appears to be an effective screening tool to standardize monitoring of isotretinoin side effects in the pediatric population., (Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

The direct and clinically obvious medical sequelae of acne vulgaris are well described. Physical comorbidities associated with classic acne are quite rare. Often more difficult to detect and measure are the short- and long-term psychosocial consequences of acne. These frequently are devastating and life-altering and in some cases are life-threatening., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

It is clear that acne vulgaris often has medical and psychosocial implications that can range from mild to severe. To minimize these risks, evaluation and appropriate treatment are necessary, even in the younger pediatric patient. This article provides an overview of the current information on the topical and systemic treatment of acne, including innovative delivery options and new formulations and combinations of existing medications., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Objectives: The goals were to assess the degree of improvement of facial acne after treatment with the 0.04% tretinoin microsphere gel (TMG) among patients 8 to 12 years of age and to assess tolerability and safety., Methods: An open-label study was conducted with 40 patients 8 to 12 years of age (mean age: 10.7 years) with mild/moderate acne, defined on the basis of Evaluator's Global Severity Score (EGSS) values between 2 and 3. Patients were treated with the 0.04% TMG for 12 weeks and were evaluated at baseline and weeks 3, 6, and 12. Primary end points were changes in EGSS and Alternative Evaluator's Global Severity Score values; the secondary efficacy end point was the Investigator's Global Evaluation of treatment responses at week 12., Results: The mean EGSS value decreased significantly from baseline to week 12 (2.6 vs 2.1; P < .001), with 75% of cases being graded as almost clear or mild. The mean Alternative Evaluator's Global Severity Score value decreased from 3.1 to 2.4 during the 12-week period (P < .001). The mean Investigator's Global Evaluation score was 3.39 at week 12, indicating moderate improvement of acne. Treatment-associated adverse events were minimal, with mild skin irritation being most commonly recorded, generally in the first 3 weeks of therapy., Conclusions: The 0.04% TMG pump was effective and safe for the treatment of acne vulgaris in this 8- to 12-year-old population, and the treatment was generally well tolerated. Additional studies in this population are recommended, to confirm these results.

The diagnosis of acne usually can be made on the basis of a history and physical examination. The differential diagnosis includes a variety of possible causes and differs according to age group (mid-childhood, 1-7 years of age; pre-, peri-, and early pubertal, 8-11 years of age; pubertal/postpubertal, >or=12 years of age). The presentation of acne in adolescents tends to include both noninflammatory and inflammatory lesions, whereas in younger patients noninflammatory comedones are typical. Keratosis pilaris affecting the cheeks sometimes may be confused with early acne vulgaris. Screening tests, particularly bone age, may be considered to support the clinical diagnosis in younger children. Further testing usually is not indicated unless patients show signs of virilization., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

The demographic profile of facial acne vulgaris has changed during the past several decades; 12 years of age is no longer the low end of the "normal" range for onset of acne. The available epidemiologic evidence raises more questions than it answers regarding the etiology of this downward shift. More study is needed to clarify whether the trend toward an earlier onset of puberty in the United States has influenced the clinical picture of acne. Additional research will help advance understanding of the spectrum of pathophysiologic changes in acne in younger pediatric patients and whether it varies from that found in individuals in whom the onset of acne occurs at approximately 12 years of age or later., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Background: Acne vulgaris is a common chronic skin disease affecting roughly 15 percent of the general population and up to 85 percent of adolescents and young adults. Adapalene, a synthetic naphthoic acid derivative with retinoid activity, has demonstrated good clinical efficacy in the treatment of acne if used with full compliance., Objectives: To evaluate the efficacy and assess safety of a new adapalene formulation, adapalene 0.1% lotion, versus the lotion vehicle in subjects with acne vulgaris., Methods: Subjects were randomized to receive either adapalene 0.1% lotion or its vehicle once daily for 12 weeks in two multicenter, randomized, vehicle-controlled, double-blind, parallel group studies. Efficacy was evaluated using two co-primary endpoints: Investigator Global Assessment (IGA) of success rate (defined as the proportion of subjects who achieved at least a two point reduction, on a 5-point scale, from baseline to week 12 in IGA score); and the absolute change from baseline to week 12 in total, inflammatory and non-inflammatory lesions. Signs of local skin irritation and routine clinical safety parameters were evaluated throughout both studies., Results: In total, 2,141 subjects were included in the two studies: 1,068 patients received adapalene 0.1 percent lotion and 1073 received the vehicle. In both studies, adapalene 0.1% lotion was shown to be significantly more effective than its vehicle in improvement in the IGA success rate. Adapalene 0.1% lotion was also significantly superior to its vehicle in all three lesion reduction measures: total, inflammatory and non-inflammatory. Reports of application site skin irritation in the adapalene 0.1% lotion treatment group were transient and mild or moderate in severity, with only a few being severe. Additionally, according to patient surveys, the lotion formulation was found to be easily spreadable, easily absorbed and pleasant to use., Conclusion: Adapalene 0.1% lotion used once a day for 12 weeks is effective and well tolerated in the treatment of acne vulgaris.

Purpose: To evaluate the safety and efficacy of dapsone gel 5% in the treatment of acne when used in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer., Methods: This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily., Results: By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity., Conclusion: Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.

Treatments for mild to moderately severe acne usually combine retinoid and antimicrobial therapy. Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12-week, multicenter, double-blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52-week safety follow-up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA's effects on acne lesion prevalence in 12- to 18-year-old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p < or = 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris.

It is well known that the setting of clinical trials for registration studies do not necessarily represent efficacy seen in clinical practice, where physicians have the flexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label, multicenter, community-based study, 544 patients who were dissatisfied with their current acne treatment received tretinoin gel microsphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was high (defined as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At week 12, the mean modified Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated significant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compliance.

Acne vulgaris is a highly prevalent, multifactorial disease process affecting the pilosebaceous units of the dermis. The effects of acne are profound both physically and psychosocially across all age groups and ethnicities; therefore, prompt recognition and appropriate treatment are critical. Pharmacotherapeutic approaches range from simple monotherapy to multimodal treatments with a variety of topical and systemic agents. Optimal patient outcomes in acne management, however, are based both on treatment efficacy as well as overall patient satisfaction. In an effort to comprehensively address these key clinical considerations in acne management, we examine the diverse nature of acne patients, the factors in optimizing treatment outcomes, and the clinical impact of current medications, particularly topical combination therapy.

Acne vulgaris can be easy to diagnose yet difficult to evaluate and manage, especially when it presents in infancy and childhood. The differential diagnosis of acne varies by age and, in some cases, may warrant a work-up in order to rule out underlying systemic abnormalities. Likewise, treatment strategies can be influenced by the patient's age. In this article, we present an overview of the clinical presentations of acne by age, an approach to patient evaluation, and a general strategy for management of this common and important disease.

Infantile acne is a rare occurrence. It is more common in boys and predominately occurs on the cheeks in infants between the ages of 1 and 16 months. Clinically, the lesions range from comedones to inflammatory papulopustules to cysts. Successful therapies include topical tretinoin, benzoyl peroxide and topical and oral erythromycin. For more serious cases, oral isotretinoin (Accutane) has been reported to successfully treat recalcitrant infantile cystic acne. We describe two additional patients with infantile cystic acne treated successfully with oral isotretinoin. The dose of isotretinoin used ranged from 0.2 mg/kg/day to 1.5 mg/kg/day. The treatment duration varied from 5 to 14 months. Careful monthly monitoring is recommended because of the many side effects reported with isotretinoin. Practical tips for the administration of oral isotretinoin in infants are reviewed.

Acne, one of the most common skin diseases, affects approximately 85% of the adolescent population, and occurs most prominently at skin sites with a high density of sebaceous glands such as the face, back, and chest. Although often considered a disease of teenagers, acne is occurring at an increasingly early age. Rosacea is a chronic facial inflammatory dermatosis characterized by flushing (or transient facial erythema), persistent central facial erythema, inflammatory papules/pustules, and telangiectasia. Both acne and rosacea have a multifactorial pathology that is incompletely understood. Increased sebum production, keratinocyte hyper-proliferation, inflammation, and altered bacterial colonization with Propionibacterium acnes are considered to be the underlying disease mechanisms in acne, while the multifactorial pathology of rosacea is thought to involve both vasoactive and neurocutaneous mechanisms. Several advances have taken place in the past decade in the research field of acne and rosacea, encompassing pathogenesis and epidemiology, as well as the development of new therapeutic interventions. In this article, we provide an overview of current perspectives on the pathogenesis and treatment of acne and rosacea, including a summary of findings from recent landmark pathophysiology studies considered to have important implications for future clinical practice. The advancement of our knowledge of the different pathways and regulatory mechanisms underlying acne and rosacea is thought to lead to further advances in the therapeutic pipeline for both conditions, ultimately providing a greater array of treatments to address gaps in current management practices.

Acne vulgaris is a common and chronic skin disease, and is a frequent source of morbidity for affected patients. Treatment of acne vulgaris is often difficult due to the multifactorial nature of this disease. Combination therapy, such as that containing clindamycin and benzoyl peroxide, has become the standard of care. Several fixed formulations of clindamycin 1% and benzoyl peroxide of varying concentrations are available and have been used with considerable success. The major limitation is irritation and dryness from higher concentrations of benzoyl peroxide, and a combination providing optimal efficacy and tolerability has yet to be determined. Recently, a clindamycin and benzoyl peroxide 3.75% fixed combination formulation was developed. Studies have suggested that this formulation may be a safe and effective treatment regimen for patients with acne vulgaris. Here, we provide a brief review of acne pathogenesis, benzoyl peroxide and clindamycin, and profile a new Clindamycin-BP 3.75% fixed combination gel for the treatment of moderate-to-severe acne vulgaris.

Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle. Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne. This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne. The intent-to-treat population included a total of 181 participants (DMT310, N = 91; placebo, N = 90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (–15.64 vs −10.84, P <.001); noninflammatory lesion counts at week 12 (–18.26 vs −12.41, P <.001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P <.001). No serious treatment related adverse events occurred. DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne. [ABSTRACT FROM AUTHOR]