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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01326780
Other study ID # CA-P-8023
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 31, 2011
Est. completion date March 31, 2012

Study information

Verified date October 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
1.2% JNJ 10229570-AAA
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
2.4% JNJ 10229570-AAA
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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