NCT01326780

A Study of a New Drug Treatment for Acne

A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Detailed description

Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	1.2% JNJ 10229570-AAA	1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
DRUG	2.4% JNJ 10229570-AAA	2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
DRUG	3.6% JNJ 10229570-AAA	3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
OTHER	Vehicle control	Color matched cream vehicle, applied once daily to the face for 12 weeks

Timeline

• Start date: 2011-03-31
• Primary completion: 2012-03-31
• Completion: 2012-03-31
• First posted: 2011-03-31
• Last updated: 2019-10-16
• Results posted: 2018-12-11

Locations

18 sites across 1 country: United States