Data: EpiDuo Forte Shows Benefit in Severe Inflammatory Acne

New data suggest that Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% from Galderma, recently approved for the treatment of moderate to severe acne vulgaris, may have benefit for the topical treatment of severe inflammatory acne. Data published for the in the December issue of the Journal of Drugs in Dermatology (JDD) show that Epiduo Forte Gel as a once-daily, single agent was statistically superior to vehicle in treating patients with severe inflammatory acne (Investigator’s Global Assessment [IGA] of 4).

The unique study design targeted a high proportion (50%) of patients with severe inflammatory acne, along with an extremely high number of baseline lesions (a total of 109-114 lesions on average across groups) and no more than 2 nodules.

The study objectives were as follows:

1. to demonstrate superior efficacy of 0.3% A/BPO vs. vehicle for up to 12 weeks in moderate and severe acne,
2. to demonstrate superior efficacy of 0.3% A/BPO vs. vehicle in the subgroup of subjects with severe acne,and
3. to assess the superiority of 0.3% A/BPO vs. 0.1% A/BPO in the subgroup of subjects with severe acne

The trial was to be considered a success if study objectives 1 and 2 were met.

Patients with severe inflammatory acne were randomized into three treatment groups: 0.3% A/BPO, 0.1% A/BPO or vehicle groups. At week 12, the 0.3% A/BPO group was superior to vehicle in terms of success rate and lesion count reduction and had a similar safety profile as 0.1% A/BPO. 

In this study, 0.3% A/BPO was superior to vehicle for both IGA success rate and change in inflammatory (IN) and non-inflammatory (NIN) lesion counts. The definition used for success (clear or almost clear) in the severe subgroup required a stringent 3-grade change.