Galderma reports ‘positive phase III trial results for 0.3% A/BPO for treatment of acne’

Galderma announced positive phase III trial results for its adapalene 0.3 percent/benzoyl peroxide 2.5 percent (0.3 percent A/BPO), which is a topical, antibiotic-free investigational drug for the treatment of acne.

The potential therapy contains a higher concentration of adapalene than that contained in its Epiduo Gel 0.1 percent/2.5 percent (0.1 percent A/BPO) and is currently being evaluated by the US Food and Drug Administration.

Data from the trials will be presented at the 73rd American Academy of Dermatology annual meeting, which will be held in San Francisco between March 20th and 24th.

During the study, more than 503 patients aged 12 and over were treated with either 0.3 percent A/BPO, 0.1 percent A/BPO or vehicle once daily for 12 weeks.

The results revealed 0.3 percent A/BPO enjoyed a superior success rate compared the vehicle (33.7 percent vs 11 percent) for those with moderate and severe acne, while those with severe acne only experienced a rate of 31.9 percent compared to 11.8 percent for the vehicle.

Dr. Jonathan Weiss, from Gwinnett Dermatology PC and Gwinnett Clinical Research Center and lead author, commented: "This phase III pivotal trial which observed a fixed-dose combination of adapalene successfully met its two endpoints consisting of superior efficacy compared to vehicle in the overall patient population (patients with moderate and severe acne) and greater efficacy in the sub-population (patients with severe acne only).”