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

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)

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