Acne Vulgaris Clinical Trial
Official title:
A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
Verified date | October 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 431 |
Est. completion date | March 31, 2012 |
Est. primary completion date | March 31, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Academic Dermatology Associates | Albuquerque | New Mexico |
United States | Northwestern University | Chicago | Illinois |
United States | Thomas J. Stephens & Associates, Inc. | Colorado Springs | Colorado |
United States | Research Across America | Dallas | Texas |
United States | Horizons Clinical Research Ctr., LLC | Denver | Colorado |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Penn State Medical Center | Hershey | Pennsylvania |
United States | Reliance Clinical Testing Services | Irving | Texas |
United States | North Florida Dermatology | Jacksonville | Florida |
United States | Dermatology Specialists Research, Inc | Louisville | Kentucky |
United States | Hilltop Research | Miamiville | Ohio |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | TKL Research | Rochelle Park | New Jersey |
United States | Hilltop Research | Saint Petersburg | Florida |
United States | University Clinical Trials, Inc. | San Diego | California |
United States | University of California, San Diego | San Diego | California |
United States | Gwinnett Clinical Research | Snellville | Georgia |
United States | Yardley Dermatology Associates | Yardley | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total Acne Lesion Counts | Change in lesion counts between baseline and end of study | Baseline to Week 12 | |
Secondary | Change From Baseline in the Non-inflammatory Acne Lesion Counts | Change in sum of open and closed comedones. | Baseline through Week 12 | |
Secondary | Change From Baseline in the Inflammatory Acne Lesion Counts | Change in sum of papules and pustules | Baseline through Week 12 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. |
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