A Study of a New Drug Treatment for Acne

NCT ID: NCT01326780

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1.2% Facial Cream

1.2% JNJ 10229570-AAA

Group Type: EXPERIMENTAL

1.2% JNJ 10229570-AAA

Intervention Type: DRUG

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

2.4% Facial Cream

2.4% JNJ 10229570-AAA

Group Type: EXPERIMENTAL

2.4% JNJ 10229570-AAA

Intervention Type: DRUG

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

3.6% Facial Cream

3.6% JNJ 10229570-AAA

Group Type: EXPERIMENTAL

3.6% JNJ 10229570-AAA

Intervention Type: DRUG

3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks

0% Facial Cream

Vehicle control

Group Type: PLACEBO_COMPARATOR

Vehicle control

Intervention Type: OTHER

Color matched cream vehicle, applied once daily to the face for 12 weeks

Interventions

1.2% JNJ 10229570-AAA

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

Intervention Type: DRUG

2.4% JNJ 10229570-AAA

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

Intervention Type: DRUG

3.6% JNJ 10229570-AAA

3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks

Intervention Type: DRUG

Vehicle control

Color matched cream vehicle, applied once daily to the face for 12 weeks

Intervention Type: OTHER

Other Intervention Names

Not yet marketed; Not yet marketed; Not yet marketed; Not marketed

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson Varughese

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

University of California, San Diego

San Diego, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, United States

Horizons Clinical Research Ctr., LLC

Denver, Colorado, United States

North Florida Dermatology

Jacksonville, Florida, United States

Hilltop Research

St. Petersburg, Florida, United States

Gwinnett Clinical Research

Snellville, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Dermatology Specialists Research, Inc

Louisville, Kentucky, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

TKL Research

Rochelle Park, New Jersey, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Wake Research Associates

Raleigh, North Carolina, United States

Hilltop Research

Miamiville, Ohio, United States

Penn State Medical Center

Hershey, Pennsylvania, United States

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

Research Across America

Dallas, Texas, United States

Reliance Clinical Testing Services

Irving, Texas, United States

Countries

United States

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA's Drug Finder

Other Identifiers

CA-P-8023

Identifier Type: -

Identifier Source: org_study_id