Trial Outcomes & Findings for Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face (NCT NCT00952523)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

162 participants

Primary outcome timeframe

three weeks

Results posted on

2012-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tretinoin & Adapalene-Benzoyl Peroxide Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Overall Study STARTED	162
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Tretinoin & Adapalene-Benzoyl Peroxide Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Overall Study Withdrawal by Subject	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tretinoin & Adapalene-Benzoyl Peroxide n=162 Participants Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Age Continuous	31 years STANDARD_DEVIATION 8.2 • n=99 Participants
Sex: Female, Male Female	141 Participants n=99 Participants
Sex: Female, Male Male	21 Participants n=99 Participants
Region of Enrollment United States	162 participants n=99 Participants

PRIMARY outcome

Timeframe: three weeks

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.

Outcome measures

Outcome measures
Measure	Tretinoin Facial Gel n=162 Participants Tretinoin facial gel in a 0.04% Pump	Adapalene-Benzoyl Peroxide Facial Gel n=162 Participants Adapalene 0.1% and Benzoyl peroxide 2.5%
Facial Irritation and Cutaneous Effects Erythema	1.5 Scores on a Scale Standard Deviation 3.8	5.4 Scores on a Scale Standard Deviation 11.8
Facial Irritation and Cutaneous Effects Dryness	3.1 Scores on a Scale Standard Deviation 6.1	7.8 Scores on a Scale Standard Deviation 10.3
Facial Irritation and Cutaneous Effects Burning/Stinging	1.9 Scores on a Scale Standard Deviation 4.0	5.8 Scores on a Scale Standard Deviation 6.5
Facial Irritation and Cutaneous Effects Itching	1.0 Scores on a Scale Standard Deviation 2.3	2.9 Scores on a Scale Standard Deviation 4.4

Adverse Events

Tretinoin Facial Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adapalene-Benzoyl Peroxide Facial Gel

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