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A Study of Acne Treatment in Children Ages 9 to 11

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Retin-A Micro 0.04% facial acne treatment
Drug: Vehicle control
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description Retin-A Micro 0.04% facial acne treatment used once daily Color matched facial gel vehicle control used once daily
Period Title: Overall Study
Started 55 55
Completed 47 54
Not Completed 8 1
Reason Not Completed
Withdrawal by Subject             2             0
Adverse Event             4             1
Lost to Follow-up             2             0
Arm/Group Title Retin-A Micro Vehicle Control Total
Hide Arm/Group Description Retin-A Micro 0.04% facial acne treatment used once daily Color matched facial gel vehicle control used once daily Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 55 participants 110 participants
9 years 5 4 9
10 Years 21 17 38
11 Years 29 34 63
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
44
  80.0%
38
  69.1%
82
  74.5%
Male
11
  20.0%
17
  30.9%
28
  25.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 55 participants 110 participants
55 55 110
Subject Reached Puberty  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 55 participants 110 participants
Yes 17 21 38
No 38 34 72
Fitzpatrick Score   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 55 participants 110 participants
I 2 1 3
II 17 12 29
III 11 16 27
IV 14 15 29
V 8 9 17
VI 3 2 5
[1]
Measure Description: Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).
1.Primary Outcome
Title Change From Baseline in Total Non-inflammatory Lesion Count
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
-19.9  (4.13) -9.7  (4.42)
2.Secondary Outcome
Title Change From Baseline in Lesion Counts
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
Comedones -19.85  (4.13) -9.67  (4.42)
Inflammatory -0.63  (1.16) 0.54  (1.23)
Total Lesions -21.87  (4.64) -10.88  (4.97)
Open Comedones -4.10  (1.77) -2.86  (1.87)
Closed Comedones -15.16  (2.92) -6.09  (3.14)
Papules -0.62  (0.75) -0.48  (0.79)
Pustules -0.17  (0.77) 1.04  (0.81)
3.Secondary Outcome
Title Measurement of Success 1
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Measure Type: Number
Unit of Measure: Participants
Clear/Almost Clear 11 11
At Least 2 Grades Improvement 15 12
4.Secondary Outcome
Title Measurement of Success 2
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Measure Type: Number
Unit of Measure: Participants
Clear/Almost Clear 10 10
At Least 2 Grades Improvement 8 8
5.Secondary Outcome
Title Measurement of Success 3
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Measure Type: Number
Unit of Measure: Participants
Success 31 27
No Success 16 27
6.Secondary Outcome
Title Global Assessment
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description:
Retin-A Micro 0.04% facial acne treatment used once daily
Color matched facial gel vehicle control used once daily
Overall Number of Participants Analyzed 47 54
Measure Type: Number
Unit of Measure: Participants
Excellent 12 7
Good 19 20
Fair 11 9
No Change 5 18
Worse 0 0
Time Frame 12 Weeks
Adverse Event Reporting Description Subjects asked if they experienced adverse events at each visit.
 
Arm/Group Title Retin-A Micro Vehicle Control
Hide Arm/Group Description Retin-A Micro 0.04% facial acne treatment used once daily Color matched facial gel vehicle control used once daily
All-Cause Mortality
Retin-A Micro Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Retin-A Micro Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      1/55 (1.82%)    
Gastrointestinal disorders     
Appendicitis * 1  0/55 (0.00%)  0 1/55 (1.82%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Retin-A Micro Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/55 (45.45%)      7/55 (12.73%)    
Infections and infestations     
Nasopharyngitis † 1  3/55 (5.45%)  3 3/55 (5.45%)  3
Pharyngitis Streptococcal † 1  3/55 (5.45%)  3 0/55 (0.00%)  0
Upper Respiratory Tract Infection † 1  2/55 (3.64%)  2 3/55 (5.45%)  3
Injury, poisoning and procedural complications     
Sunburn † 1  4/55 (7.27%)  4 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Irritation † 1  13/55 (23.64%)  13 1/55 (1.82%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Lineberry, Associate Director, Clinical Operations
Organization: Valeant Pharmaceuticals International, Inc
Phone: 949-973-1153
EMail: David.Lineberry@valeant.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00907335    
Other Study ID Numbers: CA-P-6397
First Submitted: May 20, 2009
First Posted: May 22, 2009
Results First Submitted: November 30, 2010
Results First Posted: March 11, 2011
Last Update Posted: February 15, 2012