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Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

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ClinicalTrials.gov Identifier: NCT00919191
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : March 10, 2010
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: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Tretinoin gel
Drug: Adapalene and Benzoyl peroxide
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Hide Arm/Group Description One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
Period Title: Overall Study
Started 26
Completed 26
Not Completed 0
Arm/Group Title Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Hide Arm/Group Description One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
29.1  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
26
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Comparative Assessment of Facial Irritation and Cutaneous Effects.
Hide Description Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe
Time Frame Daily, for 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants used both gels concurrently, on opposite sides of the face (split-face model)
Arm/Group Title Tretinoin Facial Gel Adapalene Benzoyl Peroxide Facial Gel
Hide Arm/Group Description:
Tretinoin Facial Gel used once daily on one side of the face in a split face model
Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Cumulative Erythema 1.1  (1.2) 2.7  (7.8)
Cumulative Dryness 3.2  (5.3) 6.2  (9.9)
2.Secondary Outcome
Title Self Assessment of Burning/Stinging and Itching
Hide Description Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe
Time Frame Daily, for 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tretinoin Facial Gel Adapalene Benzoyl Peroxide Facial Gel
Hide Arm/Group Description:
Tretinoin Facial Gel used once daily on one side of the face in a split-face model
Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Cumulative Burning/Stinging 1.4  (2.1) 3.7  (4.8)
Cumulative Itching 0.7  (0.7) 1.9  (3.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Hide Arm/Group Description One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
All-Cause Mortality
Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tretinoin and Adapalene Benzoyl Peroxide Facial Gels
Affected / at Risk (%)
Total   0/26 (0.00%) 
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
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00919191     History of Changes
Other Study ID Numbers: CA-P-6805
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: December 28, 2009
Results First Posted: March 10, 2010
Last Update Posted: February 15, 2012