Investigation of the effect of adapalene 0.3%/benzoyl peroxide 2.5% gel in Korean patients with acne: a randomized, double-blind clinical trial, with a histopathological and immunohistochemical study.

BACKGROUND: Acne vulgaris poses significant physical and psychological challenges worldwide. Data of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) for acne treatment in Asian patients is limited. METHODS: In this randomized double-blind clinical trial, 49 Korean patients with moderate-to-severe acne and scars were assigned to the A0.3/BPO2.5 (N.=37) or vehicle (N.=12) group. Acne and acne scar severity scores were assessed at baseline and 4, 8, 12, and 24 weeks. The primary outcomes were treatment success rate (reduction of ≥2 Investigator's Global Assessment grade and reaching a grade of 0 or 1) and proportional acne lesion and scar count reduction against the baseline. To assess histological changes, 2-mm punch biopsies were performed at baseline and week 24 on the respective inflammatory lesions or scars. RESULTS: At week 24, the A0.3/BPO2.5 group had a significantly higher treatment success rate than the vehicle group. The total acne count, inflammatory lesion count, and non-inflammatory lesion count percentages (against baselines) with A0.3/BPO2.5 and the vehicle were 12.1% vs. 96.7%, 8.0% vs. 101.2%, and 13.3% vs. 98.9%, respectively (all P<0.001). Scar count percentages (against baselines) with A0.3/BPO2.5 and the vehicle were 27.3% and 96.5%, respectively (P<0.001). Significant elevations in collagen 1 and 3, elastin, CK15, and p63 levels, with increases of 172.7%, 230.6%, 176.5%, 286.2%, and 105.9%, respectively, in comparison to baseline (all P<0.05). No major adverse events leading to discontinuation were observed. CONCLUSIONS: A0.3/BPO2.5 was an effective and safe treatment for acne and acne scars in Asian patients supported by robust histopathological and immunohistochemical evidence.

Management of comedonal acne vulgaris with fixed-combination topical therapy.

BACKGROUND: Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Clinically, it is characterized by a combination of open and closed comedones (formally referred to as noninflammatory lesions) and inflammatory papules and pustules. Comedonal acne is more typical in young adolescents, but can occur in combination with inflammatory papules and pustules at any time. Topical retinoids have long been advocated for the treatment of comedonal acne. AIMS: Given the increasing recognition of the inflammatory nature of acne and the synergistic benefits seen with fixed combinations we review the latest clinical data to provide guidance on optimal management of comedonal acne. METHODS: An English language literature search of Medline, EMBASE, and the Web of Science using key terms (acne, comedonal, noninflammatory, clinical trials) was conducted, and relevant articles reviewed. RESULTS: Comparative data is sparse, but we show the importance of fixed combinations with and without retinoids, where treatment benefits are comparable. Adapalene 0.1%-benzoyl peroxide 2.5% gel has been shown to be comparable to clindamycin 1%-benzoyl peroxide 5% gel, and adapalene 0.3%-benzoyl peroxide 2.5% gel. A meta-analysis suggested that clindamycin 1.2%-benzoyl peroxide 2.5% gel was more effective than clindamycin-benzoyl peroxide 5% gel in noninflammatory lesions, and two equivalent clinical programs suggest additional benefits of higher doses of benzoyl peroxide (3.75% vs 2.5%) in this fixed combination. CONCLUSIONS: Clindamycin 1.2%-benzoyl peroxide 3.75% gel may afford similar benefits to adapalene 0.3%-benzoyl peroxide 2.5% gel in this sometimes difficult to treat patient population.

Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes.

BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I-VI.

METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.

RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV-VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were "none" or "mild" for all measures.

SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.

Clinicaltrials.gov registry: NCT01880320

J Drugs Dermatol. 2017;16(6):574-581.

Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender.

BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.

METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.

RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.

CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.

Clinicaltrials.gov registry: (NCT01880320)

J Drugs Dermatol. 2017;16(6):582-589.

Adapalene 0.1%/benzoyl peroxide 2.5% gel reduces the risk of atrophic scar formation in moderate inflammatory acne: a split-face randomized controlled trial.

BACKGROUND: The efficacy of current topical acne treatments in mitigating the potential for acne scarring is not known. OBJECTIVE: To evaluate the effect of adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO) gel compared to vehicle in reducing the risk of acne scarring. METHODS: Multicentre, randomized, investigator-blinded, vehicle-controlled, split-face study conducted over 6 months. Subjects were adults with active moderate facial acne vulgaris and at least 10 atrophic acne scars at baseline. Efficacy evaluations included counts of atrophic acne scars and primary acne lesions as well as a Scar Global Assessment (SGA; 5-point scale). RESULTS: After 6 months treatment, scar counts remained stable with A/BPO while increasing by approximately 25% with vehicle (mean scar count 11.58 vs. 13.55, respectively, at Month 6; P = 0.036). The percentage of subjects with a SGA of 'almost clear' (hardly visible scars) increased from 9.7% to 45.2% with A/BPO, whereas it did not change with vehicle (P = 0.0032). Total acne lesion counts decreased by 65% with A/BPO and 36% with vehicle (mean lesion count 8.5 vs. 16.1, respectively, at Month 6; P < 0.001). LIMITATIONS: Relatively small study group (31 subjects). CONCLUSION: Topical long-term treatment with A/BPO is effective in reducing the risk of atrophic scars and improving the global severity of scarring.