A Study of a New Drug Treatment for Acne

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: 1.2% JNJ 10229570-AAA
* Drug: 2.4% JNJ 10229570-AAA
* Drug: 3.6% JNJ 10229570-AAA
* Other: Vehicle control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol If female of childbearing potential, must take a pregnancy test and have a negative result Females of childbearing potential must also agree to use an adequate method of birth control, which would include: systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study) Condom with spermicide IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods Exclusion Criteria: Known sensitivity to any of the ingredients in the study medication More than 3 nodulocystic acne lesions Use of acne treatments, therapies or medications within protocol-specified timeframes Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety Excessive facial hair that may interfere with application of the medication and/or evaluations

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.2% Facial Cream<br>1.2% JNJ 10229570-AAA | Drug: 1.2% JNJ 10229570-AAA<br>* 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks<br>* Other names: Not yet marketed;|
| Experimental: 2.4% Facial Cream<br>2.4% JNJ 10229570-AAA | Drug: 2.4% JNJ 10229570-AAA<br>* 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks<br>* Other names: Not yet marketed;|
| Experimental: 3.6% Facial Cream<br>3.6% JNJ 10229570-AAA | Drug: 3.6% JNJ 10229570-AAA<br>* 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks<br>* Other names: Not yet marketed;|
| Placebo Comparator: 0% Facial Cream<br>Vehicle control | Other: Vehicle control<br>* Color matched cream vehicle, applied once daily to the face for 12 weeks<br>* Other names: Not marketed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Acne Lesion Counts | Change in lesion counts between baseline and end of study | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Non-inflammatory Acne Lesion Counts | Change in sum of open and closed comedones. | Baseline through Week 12 | 
| Change From Baseline in the Inflammatory Acne Lesion Counts | Change in sum of papules and pustules | Baseline through Week 12 | 
| Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones) | Baseline through Week 12 | 
| Percent Change From Baseline in the Inflammatory Acne Lesion Counts | Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules) | Baseline through Week 12 | 
| Percent Change From Baseline in Total Acne Lesion Counts | Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions) | Baseline through Week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Irritation, Safety, Sebum