Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris.

Objective: To compare efficacy, tolerability, and safety of two concentrations of topical SB204 and vehicle twice daily for 12 weeks in the treatment of acne vulgaris.

Design: Randomized, double-blind, placebo-controlled, three-arm, Phase 2 study.

Setting: Dominican Republic, Panama, and Honduras.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

Background: Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis.

Objective: This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris.

Methods: 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days.