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A Study of Acne Treatment in Children Ages 9 to 11

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ClinicalTrials.gov Identifier: NCT00907335
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : March 11, 2011
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Results First Submitted Date  ICMJE November 30, 2010
Results First Posted Date  ICMJE March 11, 2011
Last Update Posted Date February 15, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Change From Baseline in Total Non-inflammatory Lesion Count [ Time Frame: Baseline to Week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Change from baseline in total non-inflammatory lesions. [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ]
Change History Complete list of historical versions of study NCT00907335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
  • Change From Baseline in Lesion Counts [ Time Frame: Baseline to Week 12 ]
    Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
  • Measurement of Success 1 [ Time Frame: Week 12 ]
    Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
  • Measurement of Success 2 [ Time Frame: Week 12 ]
    Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
  • Measurement of Success 3 [ Time Frame: Week 12 ]
    Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores.
  • Global Assessment [ Time Frame: Baseline to Week 12 ]
    Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Change from baseline and percent change from baseline in each lesion type [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ]
  • 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 ]
  • 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 ]
  • Improvement from baseline in Investigator Global Assessment score (IGA # 3) [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Acne Treatment in Children Ages 9 to 11
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Retin-A Micro 0.04% facial acne treatment
    Retin-A Micro 0.04% facial acne treatment used once daily
    Other Name: facial acne treatment
  • Drug: Vehicle control
    Color-matched facial gel vehicle control used once daily
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Retin-A Micro
    Retin-A Micro 0.04% facial acne treatment used once daily
    Intervention: Drug: Retin-A Micro 0.04% facial acne treatment
  • Placebo Comparator: Vehicle Control
    Color matched facial gel vehicle control used once daily
    Intervention: Drug: Vehicle control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2010)
110
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
100
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907335
Other Study ID Numbers  ICMJE CA-P-6397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Bausch Health Americas, Inc.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP