A Study of Different Use Regimens Using Two Acne Treatments
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ClinicalTrials.gov Identifier: NCT00907257 |
Recruitment Status :
Completed
First Posted : May 22, 2009
Results First Posted : January 21, 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: Single (Investigator); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: benzoyl peroxide wash Drug: Tretinoin gel |
Enrollment | 247 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Same Time of Day | Different Times of Day |
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5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening |
Period Title: Overall Study | ||
Started | 123 | 124 |
Completed | 110 | 112 |
Not Completed | 13 | 12 |
Reason Not Completed | ||
Adverse Event | 0 | 4 |
Protocol Violation | 1 | 2 |
Lost to Follow-up | 3 | 3 |
Withdrawal by Subject | 1 | 2 |
Per IRB-Subject became vulnerable | 1 | 0 |
Moved | 1 | 0 |
Personal Reasons | 6 | 1 |
Baseline Characteristics
Arm/Group Title | Same Time of Day | Different Times of Day | Total | |
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5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening | Total of all reporting groups | |
Overall Number of Baseline Participants | 123 | 124 | 247 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 123 participants | 124 participants | 247 participants | |
18.5 (6.86) | 18.6 (6.94) | 18.5 (6.89) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 123 participants | 124 participants | 247 participants | |
Female |
60 48.8%
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66 53.2%
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126 51.0%
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Male |
63 51.2%
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58 46.8%
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121 49.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 123 participants | 124 participants | 247 participants |
123 | 124 | 247 | ||
Fitzpatrick Score
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 123 participants | 124 participants | 247 participants |
I | 8 | 5 | 13 | |
II | 31 | 29 | 60 | |
III | 44 | 52 | 96 | |
IV | 24 | 22 | 46 | |
V | 8 | 12 | 20 | |
VI | 8 | 4 | 12 | |
[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 |
Organization: | Valeant Pharmaceuticals International, Inc |
Phone: | 949-973-1153 |
EMail: | David.Lineberry@valeant.com |
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT00907257 |
Other Study ID Numbers: |
CA-P-6270 |
First Submitted: | May 20, 2009 |
First Posted: | May 22, 2009 |
Results First Submitted: | December 22, 2010 |
Results First Posted: | January 21, 2011 |
Last Update Posted: | February 15, 2012 |