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

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) (notincluding the scalp and intertriginous areas)

4. Have a minimum plaque elevation at the target lesion site of at least moderateseverity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severelesion at baseline should be identified as the target lesion

5. Have an Investigator's Global Assessment (IGA) of disease severity of at leastmoderate (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 thanpsoriasis that might interfere with the study evaluations

7. Be willing and able to understand and comply with the requirements of the study, applythe 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 surgicallysterilized or postmenopausal for at least 2 years) must have a negative urinepregnancy test having sensitivity down to at least 50 mIU/ml for hCG, begin treatmentduring a normal menstrual period and must be willing to use an acceptable method ofcontraception during the study. The following are considered acceptable methods ofbirth control for the purpose of this study: oral contraceptives, contraceptivepatches, 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 acceptablemethod of birth control if the subject becomes sexually active. Subjects entering thestudy who are on hormonal contraceptives must have been on the method for at least 90days 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 lessthan 90 days prior to Visit 1/Day 1

9. Be willing to limit sun exposure overall, maintain a reasonably constant exposure, andavoid use of tanning booths or other UV light sources during their participation inthe study

Exclusion Criteria:

1. A female subject who is pregnant, nursing, planning a pregnancy, or does not agree touse 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 theevaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, eczema,tinea corporis)

5. Have pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatmentareas 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 indicatedwashout period prior to Visit 1/Day 1

9. Would continue to receive any treatment listed in Table 8 1 during the study