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History of Changes for Study: NCT00907257
A Study of Different Use Regimens Using Two Acne Treatments
Latest version (submitted February 14, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2009 None (earliest Version on record)
2 June 3, 2009 Contacts/Locations, Arms and Interventions and Study Status
3 July 16, 2009 Recruitment Status, Study Status and Contacts/Locations
4 August 20, 2009 Study Status
5 November 30, 2009 Recruitment Status, Study Status, Study Design and Outcome Measures
6 December 22, 2010 Outcome Measures, Study Status and Results
7 March 15, 2011 Arms and Interventions, Outcome Measures, Study Design, Study Status, More Information, Adverse Events, Baseline Characteristics, Participant Flow and References
8 April 27, 2011 Study Status and References
9 October 4, 2011 Sponsor/Collaborators and Study Status
10 February 14, 2012 More Information, Sponsor/Collaborators, Study Status, Study Identification and Outcome Measures
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Study NCT00907257
Submitted Date:  May 21, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: CA-P-6270
Brief Title: A Study of Different Use Regimens Using Two Acne Treatments
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2009
Overall Status: Recruiting
Study Start: February 2009
Primary Completion: August 2009 [Anticipated]
Study Completion: August 2009 [Anticipated]
First Submitted: May 20, 2009
First Submitted that
Met QC Criteria:
May 21, 2009
First Posted: May 22, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 21, 2009
Last Update Posted: May 22, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Acne Vulgaris
Keywords: acne
irritation
objective sensory methods
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Two different products used at same time of day
Drug: benzoyl peroxide wash and tretinoin gel
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Other Names:
  • OXY Wash and
  • Retin-A Micro Pump
Active Comparator: 2
Two different products used at two different times of day
Drug: benzoyl peroxide wash and tretinoin gel
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Other Names:
  • OXY Wash and
  • Retin-A Micro Pump
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in the total acne lesions count
[ Time Frame: Baseline, Week 3, 6 and 12 ]

Secondary Outcome Measures:
1. Change from baseline and percent change from baseline in individual acne lesion counts
[ Time Frame: Baseline, Week 3, 6 and 12 ]

2. Measurement of success according to dichotomized IGA using criteria of improvement of 2 grades from baseline score or clear or almost clear grades (grades 0 or 1)
[ Time Frame: Baseline, Week 3, 6 and 12 ]

3. Change from baseline in Investigator's Global Assessment of Acne Severity (IGA) score
[ Time Frame: Baseline, Week 3, 6 and 12 ]

4. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
[ Time Frame: Throughout duration of the study (+ 30 days for spontaneously reported SAEs) ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Joyce L Hauze, MBA, CCRA
Telephone: 973-385-6104
Email: jhauze@its.jnj.com
Study Officials: Ana Rossi, MD
Study Director
Johnson & Johnson Consumer and Personal Products Worldwide
Locations: United States, Florida
Skin Care Research, Inc.
[Recruiting]
Boca Raton, Florida, United States, 33486
Contact:Principal Investigator: Marta Rendon, MD
International Dermatology Research, Inc.
[Recruiting]
Miami, Florida, United States, 33144
Contact:Principal Investigator: Alicia Barba, MD
United States, Georgia
Gwinnett Clinical Research
[Recruiting]
Snellvillle, Georgia, United States, 30078
Contact:Principal Investigator: Jonathan Weiss, MD
United States, Kentucky
Derm Research, PLLC
[Recruiting]
Louisville, Kentucky, United States, 40217
Contact:Principal Investigator: Leon Kircik, MD
United States, Minnesota
Minnesota Clinical Study Center
[Recruiting]
Fridley, Minnesota, United States, 55432
Contact:Principal Investigator: Steven Kempers, MD
United States, New Mexico
Academic Dermatology Associates
[Recruiting]
Albuquerque, New Mexico, United States, 87106
Contact:Principal Investigator: Alicia Bucko, DO
United States, New York
DermResearch Center of New York
[Recruiting]
Stony Brook, New York, United States, 11790
Contact:Principal Investigator: Elyse Rafal, MD
United States, Ohio
Dermatology Research Associates
[Recruiting]
Cincinnatti, Ohio, United States, 45230
Contact:Principal Investigator: Anne Lucky, MD
United States, Pennsylvania
Yardley Dermatology Associates
[Recruiting]
Yardley, Pennsylvania, United States, 19067
Contact:Principal Investigator: Richard Fried, MD, PhD
United States, Texas
DermResearch, Inc.
[Recruiting]
Austin, Texas, United States, 78759
Contact:Principal Investigator: Michael Jarratt, MD
United States, Virginia
Education & Research Foundation, Inc.
[Recruiting]
Lynchburg, Virginia, United States, 24501
Contact:Principal Investigator: David Wilson, MD
Virginia Clinical Research, Inc.
[Recruiting]
Norfolk, Virginia, United States, 23507
Contact:Principal Investigator: David Pariser, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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