Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 51 for:    tazarotene

Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469755
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE May 2, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date March 31, 2008
Study Start Date  ICMJE February 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Efficacy - total lesion counts [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Percent reduction in total lesion count.
Change History Complete list of historical versions of study NCT00469755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Safety - tolerability assessments and adverse event reporting [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne
Official Title  ICMJE A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-Week Treatment Switched to Tazorac® Cream, 0.1% 6-Week Treatment in Patients With Acne Vulgaris
Brief Summary To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
Detailed Description Same as above.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Adapalene Gel, 0.1%
    Apply once daily in the evening for 12 weeks
    Other Name: Differin® Gel, 0.1%
  • Drug: Tazarotene Cream, 0.1%
    Apply once daily in the evening for 12 weeks
    Other Name: Tazorac® Cream, 0.1%
  • Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
    Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks
    Other Name: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%
Study Arms  ICMJE
  • Active Comparator: 1
    Differin® Gel, 0.1% for 12 weeks
    Intervention: Drug: Adapalene Gel, 0.1%
  • Active Comparator: 2
    Tazorac® Cream, 0.1% for 12 weeks
    Intervention: Drug: Tazarotene Cream, 0.1%
  • Active Comparator: 3
    Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks
    Intervention: Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
302
Original Enrollment  ICMJE
 (submitted: May 3, 2007)
300
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
  • Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

  • Subjects with more than 3 nodulo-cystic lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, 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 NCT00469755
Other Study ID Numbers  ICMJE US10026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date March 2008

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