Clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel was safe and well-tolerated in a safety assessment of 498 patients with moderate to severe acne.

Participants were randomized to received either the study drug or vehicle in a multicenter, double-blind, controlled, 12-week study. They were stratified by severity and placed into either a moderate or severe group.

Moderate to severe reactions to the drug were rare, and typically seen early in treatment:

• Moderate erythema: 3.3%

• Moderate scaling: 1.7%

• Moderate itching: 1.2%

• Moderate burning: 0.4%

There was one report of severe erythema, as well as one of severe burning, both occurring at week 4. One case of severe stinging was reported at week 12.

Researchers concluded that the drug has a favorable safety and tolerability profile with very low incidence of moderate or severe reactions.

Citation: Webster G. Cutaneous Safety and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate-to-severe Acne Vulgaris. J Am Acad Dermatol. 2015;8(8):22-28.