A Study of Different Use Regimens Using Two Acne Treatments

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: benzoyl peroxide wash; Drug: Tretinoin gel

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research, PLLC
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York
  • Ohio
    • Cincinnatti, Ohio, United States, 45230
      • Dermatology Research Associates
  • Pennsylvania
    • Yardley, Pennsylvania, United States, 19067
      • Yardley Dermatology Associates
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Education & Research Foundation, Inc.
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: OXY Wash; Drug: Tretinoin gel; 0.04% tretinoin gel; Other Names: 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 Names: OXY Wash; Drug: Tretinoin gel; 0.04% tretinoin gel; Other Names: Retin-A Micro Pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Ana Rossi, MD, Johnson & Johnson Consumer and Personal Products Worldwide

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA's Drug Finder

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: acne; irritation; objective sensory methods
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Benzoyl Peroxide; Tretinoin
• Other Study ID Numbers: CA-P-6270