A Study of a New Drug Treatment for Acne

Phase 2

Completed

Interventions: Drug: 1.2% JNJ 10229570-AAA
Drug: 2.4% JNJ 10229570-AAA
Drug: 3.6% JNJ 10229570-AAA
Other: Vehicle control

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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Total Acne Lesion Counts	Baseline to Week 12	Change in lesion counts between baseline and end of study

Secondary Outcome Measures

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

Locations (17): Thomas J. Stephens & Associates, Inc.
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Colorado Springs, Colorado, United States
Hilltop Research
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Miamiville, Ohio, United States
Wake Research Associates
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Raleigh, North Carolina, United States
Horizons Clinical Research Ctr., LLC
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Denver, Colorado, United States
North Florida Dermatology
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Jacksonville, Florida, United States
University of California, San Diego
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San Diego, California, United States
Gwinnett Clinical Research
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Snellville, Georgia, United States
University Clinical Trials, Inc.
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San Diego, California, United States
Dermatology Specialists Research, Inc
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Louisville, Kentucky, United States
Academic Dermatology Associates
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Albuquerque, New Mexico, United States
TKL Research
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Rochelle Park, New Jersey, United States
Yardley Dermatology Associates
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Yardley, Pennsylvania, United States
Research Across America
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Dallas, Texas, United States
Reliance Clinical Testing Services
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Irving, Texas, United States
Penn State Medical Center
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Hershey, Pennsylvania, United States
Northwestern University
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Chicago, Illinois, United States
Minnesota Clinical Study Center
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Fridley, Minnesota, United States