A Study of Acne Treatment in Children Ages 9 to 11
A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age
1 other identifier
interventional
110
1 country
12
Brief Summary
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2009
Shorter than P25 for phase_2
12 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
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
March 11, 2011
CompletedFebruary 15, 2012
February 1, 2012
10 months
May 20, 2009
November 30, 2010
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Total Non-inflammatory Lesion Count
Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Baseline to Week 12
Secondary Outcomes (5)
Change From Baseline in Lesion Counts
Baseline to Week 12
Measurement of Success 1
Week 12
Measurement of Success 2
Week 12
Measurement of Success 3
Week 12
Global Assessment
Baseline to Week 12
Study Arms (2)
Retin-A Micro
EXPERIMENTALRetin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control
PLACEBO COMPARATORColor matched facial gel vehicle control used once daily
Interventions
Retin-A Micro 0.04% facial acne treatment used once daily
Color-matched facial gel vehicle control used once daily
Eligibility Criteria
You may qualify if:
- Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris
- Minimum of 20 non-inflammatory lesions (open and closed comedones)
- Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)
- Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) at baseline
You may not qualify if:
- Known sensitivity to any of the ingredients in the study medication;
- Any nodulocystic acne lesions
- Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study
- Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study
- Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
- Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
- Use of an experimental drug or device within 60 days prior to study start;
- Use of hormonal therapy within 3 months prior to study start
- History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
- Any significant medical conditions that could confound the interpretation of the study
- History of/or current facial skin cancer
- Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study
- No use of tanning booths, sun lamps, etc.
- Subject is a family member of the employee or the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Encino Research Center
Encino, California, 91436, United States
Children's Hospital and Health Center
San Diego, California, 92123, United States
Department of Dermatology, University of Miami
Miami, Florida, 33136, United States
Department of Dermatology, Northwestern University
Chicago, Illinois, 60611, United States
Dermatology Associates
Louisville, Kentucky, 40202, United States
UMDNJ-RWJ Medical School
Somerset, New Jersey, 08873, United States
SUNY Downstate Medical Center Department of Dermatology
Brooklyn, New York, 11203, United States
Dermatology Research Associates
Cincinnatti, Ohio, 45230, United States
Skin Study Center
Broomall, Pennsylvania, 19008, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
University of Texas Medical School at Houston
Houston, Texas, 77030, United States
Related Publications (1)
Eichenfield LF, Hebert AA, Schachner L, Paller AS, Rossi AB, Lucky AW. Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study. Pediatr Dermatol. 2012 Sep-Oct;29(5):598-604. doi: 10.1111/j.1525-1470.2012.01811.x. Epub 2012 Jun 19.
PMID: 22712470DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Lineberry, Associate Director, Clinical Operations
- Organization
- Valeant Pharmaceuticals International, Inc
Study Officials
- STUDY DIRECTOR
Ana Rossi, MD
Johnson & Johnson Consumer and Personal Products Worldwide
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
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
May 20, 2009
First Posted
May 22, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 15, 2012
Results First Posted
March 11, 2011
Record last verified: 2012-02