A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

Acne Vulgaris Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313728
• Other study ID #: CA-P-7966
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2011
• Last updated: February 14, 2012
• Start date: December 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.

Description:

This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Dapsone plus Tretinoin Gel
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks
• Tretinoin Gel
Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Locations

Country	Name	City	State
United States	Skin Study Center	Broomall	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expert Grader Assessment - Erythema	Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No
Primary	Expert Grader Assessment - Dryness	Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No
Secondary	Subject Assessment - Burning/Stinging	Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No
Secondary	Subject Assessment - Itching	Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No
Secondary	Subject Assessment - Tightness	Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No
Secondary	Facial Tolerance	All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).	Baseline to 2 Weeks	No

External Links

•   FDA's Drug Finder