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Trial record 16 of 339 for:    acne AND facial

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

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ClinicalTrials.gov Identifier: NCT00714714
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 2, 2009
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: Adapalene Gel
Drug: Tretinoin Gel
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combined Arms
Hide Arm/Group Description All subjects received treatment with both gels in a split-face model
Period Title: Overall Study
Started 25
Completed 24
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Combined Arms
Hide Arm/Group Description All subjects received treatment with both gels in a split-face model
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
30.36  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Assessment of Facial Irritation and Cutaneous Effects
Hide Description Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)
Time Frame cumulative daily weekday scores for two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).
Arm/Group Title Adapalene Tretinoin
Hide Arm/Group Description:
Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Ordinal data treated as interval
Erythema (cumulative scores on a scale) 4.8  (4.2) 3.9  (5.4)
Dryness (cumulative scores on a scale) 8.8  (6.2) 6.7  (8.5)
Burning/Stinging (cumulative scores on a scale) 2.0  (2.6) 2.4  (5.9)
Itching (cumulative scores on a scale) 1.4  (1.5) 0.8  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene Tretinion
Hide Arm/Group Description Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe). Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
All-Cause Mortality
Adapalene Tretinion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene Tretinion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adapalene Tretinion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (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.Linberry@valeant.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00714714     History of Changes
Other Study ID Numbers: CA-P-5893
First Submitted: July 10, 2008
First Posted: July 14, 2008
Results First Submitted: April 1, 2009
Results First Posted: September 2, 2009
Last Update Posted: February 15, 2012