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Trial record 32 of 51 for:    tazarotene

Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00829049
Recruitment Status : Terminated (Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.)
First Posted : January 26, 2009
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE January 26, 2009
Results First Submitted Date  ICMJE September 22, 2011
Results First Posted Date  ICMJE September 12, 2012
Last Update Posted Date September 12, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [ Time Frame: Baseline, Week 12 ]
Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Non-inflamed lesion counts (open/closed comedones) [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ]
Change History Complete list of historical versions of study NCT00829049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 [ Time Frame: Week 16 ]
    Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.
  • Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 [ Time Frame: Week 12 ]
    Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.
  • Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 [ Time Frame: Baseline, Week 16 ]
    Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
  • Investigator Global Assessment [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ]
  • Overall Disease Severity [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ]
  • Inflamed Lesion Counts (papules/pustules, nodules) [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
Official Title  ICMJE Not Provided
Brief Summary Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris
Detailed Description Not Provided
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: Tazarotene Cream 0.1%
    1 pea-size amount, QD x 16 weeks
    Other Name: TAZORAC® Cream 0.1%
  • Drug: Adapalene
    1 pea-size amount, QD x 16 weeks
    Other Name: Differin® Gel 0.3%
Study Arms  ICMJE
  • Active Comparator: Tazarotene Cream 0.1%
    1 pea-size amount, QD x 16 weeks
    Intervention: Drug: Tazarotene Cream 0.1%
  • Active Comparator: Adapalene Gel 0.3%
    1 pea-size amount, QD x 16 weeks
    Intervention: Drug: Adapalene
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 20, 2012)
165
Original Actual Enrollment  ICMJE
 (submitted: January 22, 2009)
180
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
  • Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria:

  • Non-compliance with washout period
  • Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
  • Allergy or sensitivity to any component of the test medications
  • Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
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 NCT00829049
Other Study ID Numbers  ICMJE MA-TAZ0702
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date August 2012

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