Trial Outcomes & Findings for Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face (NCT NCT00919191)

Results Overview

Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Daily, for 3 weeks

Results posted on

2012-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tretinoin and Adapalene Benzoyl Peroxide Facial Gels 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 Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tretinoin and Adapalene Benzoyl Peroxide Facial Gels n=26 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	29.1 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily, for 3 weeks

Population: All participants used both gels concurrently, on opposite sides of the face (split-face model)

Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe

Outcome measures

Outcome measures
Measure	Tretinoin Facial Gel n=26 Participants Tretinoin Facial Gel used once daily on one side of the face in a split face model	Adapalene Benzoyl Peroxide Facial Gel n=26 Participants Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
Comparative Assessment of Facial Irritation and Cutaneous Effects. Cumulative Erythema	1.1 Scores on a Scale Standard Deviation 1.2	2.7 Scores on a Scale Standard Deviation 7.8
Comparative Assessment of Facial Irritation and Cutaneous Effects. Cumulative Dryness	3.2 Scores on a Scale Standard Deviation 5.3	6.2 Scores on a Scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: Daily, for 3 weeks

Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe

Outcome measures

Outcome measures
Measure	Tretinoin Facial Gel n=26 Participants Tretinoin Facial Gel used once daily on one side of the face in a split face model	Adapalene Benzoyl Peroxide Facial Gel n=26 Participants Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
Self Assessment of Burning/Stinging and Itching Cumulative Itching	0.7 Scores on a Scale Standard Deviation 0.7	1.9 Scores on a Scale Standard Deviation 3.0
Self Assessment of Burning/Stinging and Itching Cumulative Burning/Stinging	1.4 Scores on a Scale Standard Deviation 2.1	3.7 Scores on a Scale Standard Deviation 4.8

Adverse Events

Tretinoin and Adapalene Benzoyl Peroxide Facial Gels

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Lineberry, Associate Director, Clinical Operations

Valeant Pharmaceuticals International, Inc

Phone: 949-973-1153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60