A Study of Different Use Regimens Using Two Acne Treatments

NCT ID: NCT00907257

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-09-30

Brief 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.

Detailed 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Same time of day

5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day

Group Type: EXPERIMENTAL

benzoyl peroxide wash

Intervention Type: DRUG

5% benzoyl peroxide wash

Tretinoin gel

Intervention Type: DRUG

0.04% tretinoin gel

Different times of day

5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Group Type: ACTIVE_COMPARATOR

benzoyl peroxide wash

Intervention Type: DRUG

5% benzoyl peroxide wash

Tretinoin gel

Intervention Type: DRUG

0.04% tretinoin gel

Interventions

benzoyl peroxide wash

5% benzoyl peroxide wash

Intervention Type: DRUG

Tretinoin gel

0.04% tretinoin gel

Intervention Type: DRUG

Other Intervention Names

OXY Wash; Retin-A Micro Pump

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Rossi, MD

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

Skin Care Research, Inc.

Boca Raton, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

Gwinnett Clinical Research

Snellville, Georgia, United States

Derm Research, PLLC

Louisville, Kentucky, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

DermResearch Center of New York

Stony Brook, New York, United States

Dermatology Research Associates

Cincinnatti, Ohio, United States

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

DermResearch, Inc.

Austin, Texas, United States

Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Countries

United States

References

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/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.

Reference Type: RESULT

PMID: 20677537 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA's Drug Finder

Other Identifiers

CA-P-6270

Identifier Type: -

Identifier Source: org_study_id