A Study of a New Drug Treatment for Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01326780
First received: March 30, 2011
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: 1.2% JNJ 10229570-AAA
Drug: 2.4% JNJ 10229570-AAA
Drug: 3.6% JNJ 10229570-AAA
Other: Vehicle control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Change in Total Acne Lesion Counts [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Change in lesion counts between baseline and end of study


Secondary Outcome Measures:
  • Change from Baseline in the Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Change in sum of open and closed comedones.

  • Change from Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Change in sum of papules and pustules

  • Change from Baseline in Intermediate Total Acne Lesion Count [ Time Frame: Baseline through Week 10 ] [ Designated as safety issue: No ]
    Change in sum of inflammatory and non-inflammatory lesions throughout the study.

  • Percent Change from Baseline in the Non-Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Percent Change in sum of open and closed comedones.

  • Percent Change from Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Percent Change in sum of of papules and pustules.

  • Percent Change from Baseline in Total Acne Lesion Counts [ Time Frame: Baseline through Week 12. ] [ Designated as safety issue: No ]
    Percent change in inflammatory lesions and non-inflammatory lesions

  • Dichotomized Assessment of Improvement of Two Grades from Baseline Score [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in weekly Investigator's Global Assessment (IGA) scores, proportion of success according to Improvement of two grades from the baseline score

  • Dichotomized Assessment of Changes from Baseline in Clear or Almost Clear Grades [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in weekly IGA scores, proportion of success according to Clear or almost clear (Grades 0 or 1)

  • Changes in Combined Investigator's Global Assessment of Acne Severity (IGA) Score [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in weekly IGA scores, proportion of success according to dichotomized IGA using a combination of the following criteria: a) Improvement of two grades from the baseline score, b) Clear or almost clear (Grades 0 or 1)


Enrollment: 431
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Not marketed

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326780

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

Additional Information:
No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01326780     History of Changes
Other Study ID Numbers: CA-P-8023
Study First Received: March 30, 2011
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Acne
Irritation
Safety
Sebum

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 17, 2014