Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Acne Treatment in Children Ages 9 to 11
This study has been completed.
First Received: May 20, 2009   Last Updated: January 14, 2010   History of Changes
Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by: Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00907335
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Retin-A Micro 0.04% facial acne treatment
Drug: Vehicle control
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:
  • Change from baseline in total non-inflammatory lesions. [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline and percent change from baseline in each lesion type [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ] [ Designated as safety issue: No ]
  • Change from baseline for each visit in Investigator's Global Assessment of Acne Severity (IGA #1 and IGA #2) score [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ] [ Designated as safety issue: No ]
  • Measurement of success according to dichotomized IGA scores (IGA #1 And IGA #2) using criteria of improvement of 2 grades from baseline score or clear or almost clear grades (grades 0 or 1) [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ] [ Designated as safety issue: No ]
  • Improvement from baseline in Investigator Global Assessment score (IGA # 3) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Retin-A Micro: Experimental
Retin-A Micro 0.04% facial acne treatment
Drug: Retin-A Micro 0.04% facial acne treatment
Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control: Placebo Comparator
Color matched facial gel vehicle control
Drug: Vehicle control
Color-matched facial gel vehicle control

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

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907335

Locations
United States, California
Children's Hospital and Health Center
San Diego, California, United States, 92123
Encino Research Center
Encino, California, United States, 91436
United States, Florida
Department of Dermatology, University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Department of Dermatology, Northwestern University
Chicago, Illinois, United States, 60611
United States, Kentucky
Dermatology Associates
Louisville, Kentucky, United States, 40202
United States, New Jersey
UMDNJ-RWJ Medical School
Somerset, New Jersey, United States, 08873
United States, New York
SUNY Downstate Medical Center Department of Dermatology
Brooklyn, New York, United States, 11203
United States, Ohio
Dermatology Research Associates
Cincinnatti, Ohio, United States, 45230
United States, Pennsylvania
Yardley Dermatology Associates
Yardley, Pennsylvania, United States, 19067
Skin Study Center
Broomall, Pennsylvania, United States, 19008
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Texas
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Johnson & Johnson Consumer & Personal Products Worldwide
Investigators
Study Director: Ana Rossi, MD Johnson & Johnson Consumer & Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Joyce Hauze - Sr. Project Manager, Clinical Operations )
Study ID Numbers: CA-P-6397
Study First Received: May 20, 2009
Last Updated: January 14, 2010
ClinicalTrials.gov Identifier: NCT00907335     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer & Personal Products Worldwide:
acne
irritation
objective sensory methods

Additional relevant MeSH terms:
Keratolytic Agents
Facial Dermatoses
Skin Diseases
Antineoplastic Agents
Acneiform Eruptions
Therapeutic Uses
Tretinoin
Benzoyl Peroxide
Sebaceous Gland Diseases
Dermatologic Agents
Pharmacologic Actions
Acne Vulgaris

ClinicalTrials.gov processed this record on February 08, 2010