According to a phase 4, 12-week, single-arm, open label, multicenter investigational study, combination therapy of adapalene 0.3%/benzoyl peroxide 2.5% gel plus oral doxycycline 100 mg twice per day (0.3% A/BPO + DOX) is safe and effective as an alternative to oral isotretinoin for treatment of severe inflammatory acne. These findings were recently published in the Journal of Drugs in Dermatology.
Combination therapy (topical retinoid and benzoyl peroxide, plus oral antibiotic) and oral isotretinoin are first-line treatment options for severe acne vulgaris. However, oral isotretinoin use has several drawbacks, including teratogenicity, adverse effects, and access restrictions.
Investigators recruited 186 patients (age ≥12 years) with severe inflammatory acne (Investigator Global Assessment [IGA] 4 and ≤4 nodulocystic lesions) who met the criteria for oral isotretinoin. Of these, 157 patients completed the study.
The treatment regimen involved daily administration of 0.3% A/BPO + DOX. A treatment arm of 0.1% A/BPO gel was also incorporated into the study as a benchmark for safety.
Each visit involved assessment of oral isotretinoin candidacy as well as evaluation of the following end points: inflammatory lesion reduction (week 12), IGA 0 (clear) or 1 (almost clear; weeks 4, 8, 12), percent lesion reduction (weeks 4, 8, 12), and subject questionnaires (week 12). Regarding candidacy for oral isotretinoin treatment, 58.1% of participants were still eligible at 4 weeks; by 12 weeks, only 19.9% were eligible.
From baseline to study end, mean inflammatory lesion counts were reduced by 66.2%±30.47% (at baseline, 44.8 [21.73]; at week 12, 14 [16.11]; P <.0001). IGA success was achieved by 37.1% of participants by study end (P <.0001). On subject questionnaire, 83.2% of participants reported being “satisfied” or “very satisfied” with study treatment, and 90.2% of subjects reported moderate symptomatic improvement.
Patients reported no serious adverse events. Treatment-emergent adverse events were documented by 46 (26.3%) participants; the events were considered to be related to treatment in 27 (15.4%) patients.
Investigators recommend 0.3% A/BPO + DOX as a safe and effective alternative to oral isotretinoin. It may be used as an alternative or before attempting oral isotretinoin treatment.
Disclosures: Funding for the study was provided by Galderma. All authors declare affiliations with Galderma.
Del Rosso JQ, Gold LS, Johnson SM, et al. Efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% gel plus oral doxycycline in subjects with severe inflammatory acne who are candidates for oral isotretinoin. J Drugs Dermatol. 2018;17(3):264-273.