An adapalene 0.3%/benzoyl peroxide 2.5% gel (0.3% A/BPO) treatment was tolerable, safe, and improved quality of life (QoL) in a study of patients of color who had moderate or severe facial acne. Additionally, the treatment was effective for helping patients achieve a clear/almost clear status according to the Investigator’s Global Assessment. The findings from this study were published in the Journal of Drugs in Dermatology.
In the open-label study, individuals of Asian (n=20), Latin-American (n=13), and black/African-American (n=17) ethnicity were enrolled if they had moderate (70%) or severe (30%) facial acne and mostly Fitzpatrick skin types IV to VI. Patients had 25 to 100 inflammatory lesions, 30 to 150 non-inflammatory lesions, and 2 or fewer acne nodules.
During a 16-week period, participants applied 0.3% A/BPO once per day in addition to a twice-daily oil control foam wash and a once-daily oil control moisturizer with sun protection factor of 30. The moisturizer with sun protection factor was reapplied throughout the day if patients were exposed to the sun.
At baseline as well as at weeks 12 and week 16, the Dermatology Life Quality Index questionnaire or Children’s Dermatology Life Quality Index (for children aged ≤16 years) questionnaires were completed. Questionnaires assessing subject satisfaction were completed at both week 12 and week 16.
Overall, approximately 88% of all participants reported they were satisfied or very satisfied with their treatment. Three-fourths (77%) of patients were satisfied or very satisfied with treatment at week 16. The majority of patients were either not bothered or somewhat bothered by treatment side effects (93%). Almost half (49%) were not bothered by side effects.
In terms of the efficacy of 0.3% A/BPO, more than half (56%) of participants achieved an Investigator’s Global Assessment score of 0 or 1, representing clear/almost clear. Additionally, the majority of patients (87%) had a good to excellent improvement in Global Assessment of Improvement.
All participants reported improvements in QoL. There was an increase in participants reporting “no effect at all” of acne on QoL from baseline to week 16 of 16% to 55%, respectively. Postinflammatory hyperpigmentation was rated very mild to moderate at baseline in all those affected (60%), whereas 75% had either no or very mild postinflammatory hyperpigmentation by week 16 (mean decrease, 27%). No adverse events associated with study discontinuation were reported.
Limitations of the study include the open-label design, the small number of patients in the overall sample, and the lack of white patients, which may limit generalizability of the findings.
The researchers concluded that moisturizers and sunscreens combined with 0.3% A/BPO gel “are essential, and, in combination with acne treatment, have been shown to lead to high levels of subject satisfaction, improved adherence, and favorable tolerability.”
Disclosure: This clinical trial was supported by Galderma R&D. Please see the original reference for a full list of authors’ disclosures.
Reference:
DuBois J, Ong GCW, Petkar G, et al. Patient-reported outcomes in acne patients with skin of color using adapalene 0.3%-benzoyl peroxide 2.5%: a prospective real-world study. J Drugs Dermatol. 2019;18(6):514.