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Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face

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ClinicalTrials.gov Identifier: NCT00952523
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : April 9, 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 Facial Gel
Drug: Adapalene/Benzoyl Peroxide Facial Gel
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tretinoin & Adapalene-Benzoyl Peroxide
Hide Arm/Group Description Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Period Title: Overall Study
Started 162
Completed 155
Not Completed 7
Reason Not Completed
Withdrawal by Subject             7
Arm/Group Title Tretinoin & Adapalene-Benzoyl Peroxide
Hide Arm/Group Description Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
31  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
141
  87.0%
Male
21
  13.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 162 participants
162
1.Primary Outcome
Title Facial Irritation and Cutaneous Effects
Hide Description Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
Time Frame three 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 in a 0.04% Pump
Adapalene 0.1% and Benzoyl peroxide 2.5%
Overall Number of Participants Analyzed 162 162
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Erythema 1.5  (3.8) 5.4  (11.8)
Dryness 3.1  (6.1) 7.8  (10.3)
Burning/Stinging 1.9  (4.0) 5.8  (6.5)
Itching 1.0  (2.3) 2.9  (4.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tretinoin Facial Gel Adapalene-Benzoyl Peroxide Facial Gel
Hide Arm/Group Description Tretinoin facial gel applied once daily in a split face model Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
All-Cause Mortality
Tretinoin Facial Gel Adapalene-Benzoyl Peroxide Facial Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tretinoin Facial Gel Adapalene-Benzoyl Peroxide Facial Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)   0/162 (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 Facial Gel Adapalene-Benzoyl Peroxide Facial Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)   0/162 (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: NCT00952523     History of Changes
Other Study ID Numbers: CA-P-7190
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: January 26, 2010
Results First Posted: April 9, 2010
Last Update Posted: February 15, 2012