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Trial record 5 of 51 for:    tazarotene

A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02886702
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE September 1, 2016
Results First Submitted Date  ICMJE July 30, 2018
Results First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE September 19, 2016
Actual Primary Completion Date August 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Treatment Success Assessed by IGA [ Time Frame: Week 12 ]
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
IGA Score [ Time Frame: Week 12 ]
Change History Complete list of historical versions of study NCT02886702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • Disease Severity None or Minimal on IGA [ Time Frame: Week 12 ]
    Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
  • Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI [ Time Frame: Week 12 ]
    Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
  • IGA Score [ Time Frame: Week 12 ]
  • PASI Score [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Official Title  ICMJE A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Brief Summary A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Tazarotene Cream 0.05%
    Tazarotene Cream 0.05% to cover only the lesions with a thin film.
    Other Name: Tazarotene
  • Drug: TAZORAC® (tazarotene) Cream 0.05%
    TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
    Other Name: Tazarotene
  • Drug: Placebo
    Placebo (vehicle of the test product) to cover only the lesions with a thin film.
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: Test
    Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
    Intervention: Drug: Tazarotene Cream 0.05%
  • Active Comparator: Reference
    TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
    Intervention: Drug: TAZORAC® (tazarotene) Cream 0.05%
  • Placebo Comparator: Placebo
    Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
    Intervention: Drug: Placebo
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: August 29, 2016)
855
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2, 2017
Actual Primary Completion Date August 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
  • Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
  • Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion Criteria:

  • A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
  • Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
  • Have a history of psoriasis unresponsive to topical treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02886702
Other Study ID Numbers  ICMJE 0453-01-01
0453 ( Other Identifier: Fougera Pharmaceuticals Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fougera Pharmaceuticals Inc.
Study Sponsor  ICMJE Fougera Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Angela C. Kaplan Fougera Pharmaceuticals Inc.
PRS Account Fougera Pharmaceuticals Inc.
Verification Date July 2018

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