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
1 other identifier
interventional
431
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedStudy Start
First participant enrolled
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2012
CompletedResults Posted
Study results publicly available
December 11, 2018
CompletedOctober 16, 2019
October 1, 2019
1 year
March 30, 2011
May 22, 2017
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total Acne Lesion Counts
Change in lesion counts between baseline and end of study
Baseline to Week 12
Secondary Outcomes (5)
Change From Baseline in the Non-inflammatory Acne Lesion Counts
Baseline through Week 12
Change From Baseline in the Inflammatory Acne Lesion Counts
Baseline through Week 12
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Baseline through Week 12
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Baseline through Week 12
Percent Change From Baseline in Total Acne Lesion Counts
Baseline through Week 12.
Study Arms (4)
1.2% Facial Cream
EXPERIMENTAL1.2% JNJ 10229570-AAA
2.4% Facial Cream
EXPERIMENTAL2.4% JNJ 10229570-AAA
3.6% Facial Cream
EXPERIMENTAL3.6% JNJ 10229570-AAA
0% Facial Cream
PLACEBO COMPARATORVehicle control
Interventions
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Color matched cream vehicle, applied once daily to the face for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of California, San Diego
San Diego, California, 92093, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915, United States
Horizons Clinical Research Ctr., LLC
Denver, Colorado, 80220, United States
North Florida Dermatology
Jacksonville, Florida, 32204, United States
Hilltop Research
St. Petersburg, Florida, 33710, United States
Gwinnett Clinical Research
Snellville, Georgia, 30078, United States
Northwestern University
Chicago, Illinois, 60611, United States
Dermatology Specialists Research, Inc
Louisville, Kentucky, 40202, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
TKL Research
Rochelle Park, New Jersey, 07662, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Hilltop Research
Miamiville, Ohio, 45147, United States
Penn State Medical Center
Hershey, Pennsylvania, 17033, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
Research Across America
Dallas, Texas, 75234, United States
Reliance Clinical Testing Services
Irving, Texas, 75062, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johnson Varughese
- Organization
- Valeant
Study Officials
- STUDY DIRECTOR
Johnson Varughese
Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
March 31, 2011
Study Start
March 31, 2011
Primary Completion
March 31, 2012
Study Completion
March 31, 2012
Last Updated
October 16, 2019
Results First Posted
December 11, 2018
Record last verified: 2019-10