A Study of Acne Treatment in Children Ages 9 to 11

• 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: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Tracking Information

• First Submitted Date: May 20, 2009
• First Posted Date: May 22, 2009
• Results First Submitted Date: November 30, 2010
• Results First Posted Date: March 11, 2011
• Last Update Posted Date: February 15, 2012
• Study Start Date: February 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 21, 2009): Change from baseline in total non-inflammatory lesions. [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and12 ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2010): 110
• Original Estimated Enrollment (submitted: May 21, 2009): 100
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Years to 11 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00907335
• Other Study ID Numbers: CA-P-6397
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bausch Health Americas, Inc.
• Study Sponsor: Bausch Health Americas, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Ana Rossi, MD; Johnson & Johnson Consumer and Personal Products Worldwide

• PRS Account: Bausch Health Americas, Inc.
• Verification Date: February 2012