A Study of Different Use Regimens Using Two Acne Treatments

Acne Vulgaris Clinical Trial

Official title:

A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907257
• Other study ID #: CA-P-6270
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2009
• Last updated: February 14, 2012
• Start date: February 2009
• Est. completion date: September 2009

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

A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Description:

Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;

• Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);

• Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);

• Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline

Exclusion Criteria:

• Known sensitivity to any of the ingredients in the study medication;

• Any nodulocystic acne lesions;

• Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;

• Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;

• Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;

• Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;

• If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;

• History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;

• Any significant medical conditions that could confound the interpretation of the study;

• Excessive facial hair that may interfere with evaluations;

• No use of tanning booths, sun lamps, etc.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• benzoyl peroxide wash
5% benzoyl peroxide wash
• Tretinoin gel
0.04% tretinoin gel

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	Dermatology Research Associates	Cincinnatti	Ohio
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Derm Research, PLLC	Louisville	Kentucky
United States	Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Gwinnett Clinical Research	Snellville	Georgia
United States	DermResearch Center of New York	Stony Brook	New York
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/mo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Facial Acne Lesion Count	Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.	Baseline to Week 12	No
Secondary	Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals	Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).	Baseline to Week 12	No
Secondary	Measurement of Success	Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.	Baseline to Week 12	No

External Links

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