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A Study of Different Use Regimens Using Two Acne Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00907257
First received: May 20, 2009
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Drug: benzoyl peroxide wash
Drug: Tretinoin gel
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Change From Baseline in Total Facial Acne Lesion Count [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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).

  • Measurement of Success [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

    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.



Enrollment: 247
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Same time of day
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
 Drug: benzoyl peroxide wash
5% benzoyl peroxide wash
Other Name: OXY Wash
Drug: Tretinoin gel
0.04% tretinoin gel
Other Name: Retin-A Micro Pump
Active Comparator: Different times of day
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
 Drug: benzoyl peroxide wash
5% benzoyl peroxide wash
Other Name: OXY Wash
Drug: Tretinoin gel
0.04% tretinoin gel
Other Name: Retin-A Micro Pump

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907257

Locations
United States, Florida
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Georgia
Gwinnett Clinical Research
Snellville, Georgia, United States, 30078
United States, Kentucky
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
DermResearch Center of New York
Stony Brook, New York, United States, 11790
United States, Ohio
Dermatology Research Associates
Cincinnatti, Ohio, United States, 45230
United States, Pennsylvania
Yardley Dermatology Associates
Yardley, Pennsylvania, United States, 19067
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
United States, Virginia
Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

Additional Information:
FDA's Drug Finder  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00907257     History of Changes
Other Study ID Numbers: CA-P-6270
Study First Received: May 20, 2009
Results First Received: December 22, 2010
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valeant Pharmaceuticals International, Inc.:
acne
irritation
objective sensory methods

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
 Tretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on June 18, 2013