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Trial record 11 of 51 for:    tazarotene

Generic Tazarotene Cream, 0.05% for the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02160665
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
G & W Laboratories Inc.

Brief Summary:
The purpose of this study is to compare the safety and efficacy profiles of Tazarotene Cream, 0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence and to demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo) in the treatment of plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Tazarotene Cream, 0.05% Drug: Vehicle Drug: Reference: Tazorac Cream, 0.05% Phase 3

Detailed Description:

This is a double-blind, randomized, parallel-group, vehicle-controlled, multicenter study of Tazarotene Cream, 0.05% in subjects with plaque psoriasis. Subjects will be randomly assigned in a 1:1:1 ratio to Test, Reference, or Vehicle.

Subjects will be admitted into the study after informed consent has been obtained and all inclusion/exclusion criteria have been met. At each visit, the same investigator (whenever possible) will grade the clinical signs of plaque psoriasis at the designated target lesion site using the Psoriasis Area Severity Index (PASI), an Investigator's Global Assessment (IGA) of disease severity will be performed (IGA scores range from 0 = none to 5 = very severe), and application site reactions (erythema, dryness, burning/stinging, erosion, edema, pain, and pruritus) will be assessed. In addition, the involved body surface area (BSA) will be determined at Visit 1 and Visit 4. Safety will be assessed by monitoring all adverse events (AEs) at each visit and a telephone contact at Day 7 (+ 4 days)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 866 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind,Randomized,Parallel-Group,Vehicle-Controlled,Multi-Center Study Comparing a Generic Tazarotene Cream, 0.05% to RLD Tazorac® Cream, 0.05% and Both Treatments to a Vehicle in the Treatment of Plaque Psoriasis
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tazarotene

Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle of Test product (G & W Laboratories, Inc.)
Drug: Vehicle
Vehicle of Test product (G & W Laboratories, Inc.)
Other Name: Placebo

Reference: Tazorac Cream, 0.05%
Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
Drug: Reference: Tazorac Cream, 0.05%
Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
Other Name: Tazorac

Active Comparator: Test:Tazarotene Cream, 0.05%
Test: Tazarotene Cream, 0.05% (G & W Laboratories, Inc.)
Drug: Tazarotene Cream, 0.05%
Tazarotene Cream, 0.05% (G & W Laboratories, Inc.)
Other Name: Test




Primary Outcome Measures :
  1. primary efficacy endpoint [ Time Frame: Week 12 ]
    The primary efficacy endpoint is the proportion of subjects with treatment success on the IGA at Visit 4/Week 12. Treatment success is defined as absent, very mild, or mild disease shown by a score of 0, 1, or 2 within the treatment area on the IGA. The primary analyses include evaluation of bioequivalence between the 2 active products and evaluations of superiority of each active treatment over the vehicle.


Secondary Outcome Measures :
  1. Proportion of subjects with disease severity [ Time Frame: Week 12 ]
    Secondary efficacy endpoints will include: 1) the proportion of subjects with disease severity at Visit 4/Week 12 consistent with absent or very mild disease shown by a score of 0 or 1 within the treatment area on the IGA

  2. the proportion of subjects with target lesion site [ Time Frame: Week 12 ]
    the proportion of subjects with target lesion site plaque elevation, scaling, and erythema scores of ≤ 1 on the PASI at Visit 4/Week 12.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be willing and able to provide written informed consent for the study
  2. Be male or female, at least 18 years of age
  3. 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)
  4. 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
  5. 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.
  6. Be in general good health and free from any clinically significant disease other than psoriasis that might interfere with the study evaluations
  7. Be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
  8. Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test having sensitivity down to at least 50 mIU/ml for hCG, begin treatment during a normal menstrual period and must be willing to use an acceptable method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1/Day 1
  9. Be willing to limit sun exposure overall, maintain a reasonably constant exposure, and avoid use of tanning booths or other UV light sources during their participation in the study

Exclusion Criteria:

  1. 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
  2. Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
  3. Have a history of psoriasis unresponsive to topical treatments
  4. Have other inflammatory skin disease in the treatment area that may confound with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, eczema, tinea corporis)
  5. Have pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters
  6. Have an unstable medical disorder, life-threatening disease, or current malignancy
  7. Have current immunosuppression
  8. Have received any treatment listed in Table 8 1 more recently than the indicated washout period prior to Visit 1/Day 1
  9. Would continue to receive any treatment listed in Table 8 1 during the study

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): NCT02160665


Locations
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United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Sponsors and Collaborators
G & W Laboratories Inc.
Investigators
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Principal Investigator: Michael Bukhalo, MD Altman Dermatology Associates

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Responsible Party: G & W Laboratories Inc.
ClinicalTrials.gov Identifier: NCT02160665     History of Changes
Other Study ID Numbers: SYM 2013-01
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
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