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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01313728 |
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Date of registration:
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10/03/2011 |
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Primary sponsor: |
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Public title:
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A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
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Scientific title:
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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 |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01313728 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David Lineberry |
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Address:
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Telephone:
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Email:
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Affiliation:
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Valeant Pharmaceuticals International, Inc. |
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Key inclusion & exclusion criteria
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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
reactions
- Subjects who use any known photosensitizing agents
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acne Vulgaris
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Intervention(s)
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Drug: Dapsone plus Tretinoin Gel
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Drug: Tretinoin Gel
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Primary Outcome(s)
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Expert Grader Assessment - Dryness
[Time Frame: Baseline to 2 Weeks]
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Expert Grader Assessment - Erythema
[Time Frame: Baseline to 2 Weeks]
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Secondary Outcome(s)
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Facial Tolerance
[Time Frame: Baseline to 2 Weeks]
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Subject Assessment - Burning/Stinging
[Time Frame: Baseline to 2 Weeks]
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Subject Assessment - Itching
[Time Frame: Baseline to 2 Weeks]
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Subject Assessment - Tightness
[Time Frame: Baseline to 2 Weeks]
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Secondary ID(s)
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CA-P-7966
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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