Conditions: Acne Vulgaris
Keywords: Acne Irritation Safety Sebum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 431
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 1.2% JNJ 10229570-AAA arm 2: 2.4% JNJ 10229570-AAA arm 3: 3.6% JNJ 10229570-AAA arm 4: Vehicle control

Interventions: intervention 1: 1.2% JNJ 10229570-AAA intervention 2: 2.4% JNJ 10229570-AAA intervention 3: 3.6% JNJ 10229570-AAA intervention 4: Vehicle control
Intervention descriptions: intervention 1: 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks intervention 2: 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks intervention 3: 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks intervention 4: Color matched cream vehicle, applied once daily to the face for 12 weeks

Protocol document: