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

May 20, 2009
February 14, 2012
February 2009
September 2009   (final data collection date for primary outcome measure)
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.
Change from baseline in the total acne lesions count [ Time Frame: Baseline, Week 3, 6 and 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00907257 on ClinicalTrials.gov Archive Site
  • 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.

  • Change from baseline and percent change from baseline in individual acne lesion counts [ Time Frame: Baseline, Week 3, 6 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Investigator's Global Assessment of Acne Severity (IGA) score [ Time Frame: Baseline, Week 3, 6 and 12 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • 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
  • 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
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.
 
Completed
247
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00907257
CA-P-6270
No
Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
Valeant Pharmaceuticals International, Inc.
February 2012

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