BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Inclusion Criteria:

• Male or non-pregnant, non-lactating female, at least 18 years of age.
• Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
• A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
• Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
• Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
• Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose > 400 IU/day during the study.
• Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.

Exclusion Criteria:

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
• History of hypersensitivity to any component of TEST or RLD.
• Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.