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Plaque PsoriasisPhase 3NCT02160665

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

A Phase 3 study testing Tazarotene Cream, 0.05% and Reference: Tazorac Cream, 0.05% in people with Plaque Psoriasis, run by G & W Laboratories Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis
What is being tested?
Tazarotene Cream, 0.05% and Reference: Tazorac Cream, 0.05%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
866 participants
Where
1 siteUnited States
Study dates
May 2014to May 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the study
  • Be male or female, at least 18 years of age
  • 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.
  • Be in general good health and free from any clinically significant disease other than psoriasis that might interfere with the study evaluations
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  • 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
  • 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
  • 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

Who cannot join

  • 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
  • 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)
  • Have pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters
  • Have an unstable medical disorder, life-threatening disease, or current malignancy
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  • Have current immunosuppression
  • Have received any treatment listed in Table 8 1 more recently than the indicated washout period prior to Visit 1/Day 1
  • Would continue to receive any treatment listed in Table 8 1 during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altman Dermatology Associates

    Arlington Heights, Illinois, 60005

Other trials in United States

About this study

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

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.

Read the 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)

Being tested
Tazarotene Cream, 0.05%, Vehicle, Reference: Tazorac Cream, 0.05%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tazarotene Cream, 0.05%Drug

    Also called Test

    Tazarotene Cream, 0.05% (G \& W Laboratories, Inc.)

  • VehicleDrug

    Also called Placebo

    Vehicle of Test product (G \& W Laboratories, Inc.)

  • Reference: Tazorac Cream, 0.05%Drug

    Also called Tazorac

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

Study groups in NCT02160665
Study groupRoleWhat they receive
VehiclePlacebo comparatorVehicle of Test product (G \& W Laboratories, Inc.)
Receives: Drug: Vehicle
Reference: Tazorac Cream, 0.05%OtherReference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
Receives: Drug: Reference: Tazorac Cream, 0.05%
Test:Tazarotene Cream, 0.05%Active comparatorTest: Tazarotene Cream, 0.05% (G \& W Laboratories, Inc.)
Receives: Drug: Tazarotene Cream, 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary efficacy endpoint

    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.

    Measured: Week 12

Secondary outcomes (2)

  1. Proportion of subjects with disease severity

    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

    Measured: Week 12

  2. the proportion of subjects with target lesion site

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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160665
Sponsor's protocol ID
SYM 2013-01
Status last verified
Nov 2016
First submitted
9 Jun 2014
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tazarotene Cream, 0.05% and Reference: Tazorac Cream, 0.05% in people with Plaque Psoriasis, run by G & W Laboratories Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary efficacy endpoint (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

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