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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT01313728
Date of registration: 10/03/2011
Primary sponsor: Valeant Pharmaceuticals International, Inc.
Public title: A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
Scientific title: An Investigator-Blind, Phase 4 Study Assessing Mitigation of Facial Irritation When Comparing the Use of Two Acne Treatment Products (Retin-A Micro® 0.1 % Pump and Aczone®) With One Treatment Product (Retin-A Micro® 0.1 % Pump) Using a Split-Face Model
Date of first enrolment: December 2010
Target sample size: 26
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   David Lineberry
Affiliation:  Valeant Pharmaceuticals International, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator

- Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc.,
prior to study start

- Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours
before they start, and during the study

- If subject is of childbearing potential, subject has been using a protocol-approved
method of birth control for a certain amount of time, and is willing to continue
using it throughout the study

Exclusion Criteria:

- Subjects who are pregnant or nursing, or intend to be during the study

- Subjects with any condition or medical history, or using any drug or medication, that
might negatively affect the subject's safety or the validity of study results, either
as listed in the protocol or in the opinion of the investigator

- Subjects who have facial hair that may obstruct or hinder the evaluation of any

- Subjects who use any known photosensitizing agents

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Acne Vulgaris
Drug: Dapsone plus Tretinoin Gel
Drug: Tretinoin Gel
Primary Outcome(s)
Expert Grader Assessment - Dryness [Time Frame: Baseline to 2 Weeks]
Expert Grader Assessment - Erythema [Time Frame: Baseline to 2 Weeks]
Secondary Outcome(s)
Facial Tolerance [Time Frame: Baseline to 2 Weeks]
Subject Assessment - Burning/Stinging [Time Frame: Baseline to 2 Weeks]
Subject Assessment - Itching [Time Frame: Baseline to 2 Weeks]
Subject Assessment - Tightness [Time Frame: Baseline to 2 Weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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