Clinical trial NCT00907335: A Study of Acne Treatment in Children Ages 9 to 11
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
irritation
objective sensory methods
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 110
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.

Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.

Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Total Non-inflammatory Lesion Count
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in Lesion Counts
timeFrame: Baseline to Week 12
measure: Measurement of Success 1
timeFrame: Week 12
measure: Measurement of Success 2
timeFrame: Week 12
measure: Measurement of Success 3
timeFrame: Week 12
measure: Global Assessment
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Encino
country: United States
facility: Encino Research Center
state: California
city: San Diego
country: United States
facility: Children's Hospital and Health Center
state: California
city: Miami
country: United States
facility: Department of Dermatology, University of Miami
state: Florida
city: Chicago
country: United States
facility: Department of Dermatology, Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Dermatology Associates
state: Kentucky
city: Somerset
country: United States
facility: UMDNJ-RWJ Medical School
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center Department of Dermatology
state: New York
city: Cincinnatti
country: United States
facility: Dermatology Research Associates
state: Ohio
city: Broomall
country: United States
facility: Skin Study Center
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Ana Rossi, MD
role: STUDY_DIRECTOR
References:
citation: 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.