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A Study of Different Use Regimens Using Two Acne Treatments

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ClinicalTrials.gov Identifier: NCT00907257
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : January 21, 2011
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Results First Submitted Date  ICMJE December 22, 2010
Results First Posted Date  ICMJE January 21, 2011
Last Update Posted Date February 15, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2011)
Change From Baseline in Total Facial Acne Lesion Count [ Time Frame: Baseline to Week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Change from baseline in the total acne lesions count [ Time Frame: Baseline, Week 3, 6 and 12 ]
Change History Complete list of historical versions of study NCT00907257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2011)
  • Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals [ Time Frame: Baseline to Week 12 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Change from baseline and percent change from baseline in individual acne lesion counts [ Time Frame: Baseline, Week 3, 6 and 12 ]
  • 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 ]
  • Change from baseline in Investigator's Global Assessment of Acne Severity (IGA) score [ Time Frame: Baseline, Week 3, 6 and 12 ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Different Use Regimens Using Two Acne Treatments
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Same time of day
    5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
    Interventions:
    • Drug: benzoyl peroxide wash
    • Drug: Tretinoin gel
  • Active Comparator: Different times of day
    5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
    Interventions:
    • Drug: benzoyl peroxide wash
    • Drug: Tretinoin gel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2011)
247
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
240
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907257
Other Study ID Numbers  ICMJE CA-P-6270
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Bausch Health Americas, Inc.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP