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
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Sponsor:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Retin-A Micro | Vehicle Control |
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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 |
Baseline Characteristics
Arm/Group Title | Retin-A Micro | Vehicle Control | Total | |
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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 | |
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[Not Specified]
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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 |
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Number Analyzed | 55 participants | 55 participants | 110 participants | |
Female |
44 80.0%
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38 69.1%
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82 74.5%
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Male |
11 20.0%
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17 30.9%
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28 25.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |