NCT02656485

A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris

A Double Blind, Placebo-Controlled, Single Center, Randomized, Sequential, Ascending 14-Day Multiple Dose Study in Subjects With Acne Vulgaris to Evaluate the Safety, Tolerability and Preliminary Efficacy of B244 Delivered as a Topical Spray

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.

Detailed description

After a screening visit and a one-week washout (if applicable), three sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of subjects. Each group of subjects will be randomized to receive the planned doses of B244 or placebo BID

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	B244	10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
DRUG	Placebo	10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

Timeline

• Start date: 2015-08-05
• Primary completion: 2016-03-01
• Completion: 2016-07-15
• First posted: 2016-01-15
• Last updated: 2017-04-05
• Results posted: 2017-04-05

Locations

1 site across 1 country: United States