A Study of a New Drug Treatment for Acne

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326780
• Other study ID #: CA-P-8023
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Acne Vulgaris

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.

External Links

•   FDA's Drug Finder