A Study of Different Use Regimens Using Two Acne Treatments

NCT00907257 | Completed Phase 4 Results

• 1 other identifier: CA-P-6270
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 12

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.

Conditions

Acne Vulgaris

Keywords

acne; irritation; objective sensory methods

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals

  Baseline to Week 12

• Measurement of Success

  Baseline to Week 12

Study Arms (2)

Same time of day

EXPERIMENTAL

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

Drug: benzoyl peroxide wash; Drug: Tretinoin gel

Different times of day

ACTIVE COMPARATOR

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

Drug: benzoyl peroxide wash; Drug: Tretinoin gel

Interventions

benzoyl peroxide wash DRUG

5% benzoyl peroxide wash

Also known as: OXY Wash

Different times of day; Same time of day

Tretinoin gel DRUG

0.04% tretinoin gel

Also known as: Retin-A Micro Pump

Different times of day; Same time of day

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (12)

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Gwinnett Clinical Research

Snellville, Georgia, 30078, United States

Location

Derm Research, PLLC

Louisville, Kentucky, 40217, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

DermResearch Center of New York

Stony Brook, New York, 11790, United States

Location

Dermatology Research Associates

Cincinnatti, Ohio, 45230, United States

Location

Yardley Dermatology Associates

Yardley, Pennsylvania, 19067, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

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

  PMID: 20677537 RESULT

Related Links

• FDA's Drug Finder

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: David Lineberry
• Organization: Valeant Pharmaceuticals International, Inc

David.Lineberry@valeant.com

949-973-1153

Study Officials

• Ana Rossi, MD

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 15, 2012
• Results First Posted: January 21, 2011

Record last verified: 2012-02

Locations

US (12)