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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.

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Tazarotene Cream 0.05% Drug: TAZORAC® (tazarotene) Cream 0.05% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 855 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Drug: Tazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
Other Name: Tazarotene

Active Comparator: Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Drug: TAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Other Name: Tazarotene

Placebo Comparator: Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Drug: Placebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Other Name: Vehicle




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886702


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Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
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Study Director: Angela C. Kaplan Fougera Pharmaceuticals Inc.
  Study Documents (Full-Text)

Documents provided by Fougera Pharmaceuticals Inc.:
Study Protocol  [PDF] December 22, 2016
Statistical Analysis Plan  [PDF] April 26, 2017


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Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02886702     History of Changes
Other Study ID Numbers: 0453-01-01
0453 ( Other Identifier: Fougera Pharmaceuticals Inc. )
First Posted: September 1, 2016    Key Record Dates
Results First Posted: August 29, 2018
Last Update Posted: August 29, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tazarotene
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs