A Study of a New Drug Treatment for Acne

A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: 1.2% JNJ 10229570-AAA; Drug: 2.4% JNJ 10229570-AAA; Drug: 3.6% JNJ 10229570-AAA; Other: Vehicle control

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.

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Thomas J. Stephens & Associates, Inc.
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Ctr., LLC
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology
    • Saint Petersburg, Florida, United States, 33710
      • Hilltop Research
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research, Inc
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Jersey
    • Rochelle Park, New Jersey, United States, 07662
      • TKL Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Miamiville, Ohio, United States, 45147
      • Hilltop Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Medical Center
    • Yardley, Pennsylvania, United States, 19067
      • Yardley Dermatology Associates
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Irving, Texas, United States, 75062
      • Reliance Clinical Testing Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1.2% Facial Cream; 1.2% JNJ 10229570-AAA	Drug: 1.2% JNJ 10229570-AAA; 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
EXPERIMENTAL: 2.4% Facial Cream; 2.4% JNJ 10229570-AAA	Drug: 2.4% JNJ 10229570-AAA; 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
EXPERIMENTAL: 3.6% Facial Cream; 3.6% JNJ 10229570-AAA	Drug: 3.6% JNJ 10229570-AAA; 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
PLACEBO_COMPARATOR: 0% Facial Cream; Vehicle control	Other: Vehicle control; Color matched cream vehicle, applied once daily to the face for 12 weeks; Other Names: Not marketed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Acne Lesion Counts	Change in lesion counts between baseline and end of study	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Non-inflammatory Acne Lesion Counts	Change in sum of open and closed comedones.	Baseline through Week 12
Change From Baseline in the Inflammatory Acne Lesion Counts	Change in sum of papules and pustules	Baseline through Week 12
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
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
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.

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Publications and helpful links

Helpful Links

• FDA's Drug Finder

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2011
• Primary Completion (ACTUAL): March 31, 2012
• Study Completion (ACTUAL): March 31, 2012

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (ESTIMATE): March 31, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Acne; Irritation; Sebum
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CA-P-8023