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

Tolmar Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Scalp Psoriasis

Treatments: Drug: Placebo; Drug: Calcipotriene and betamethasone suspension; Drug: Taclonex

Study type: Interventional

Funder types: Industry

Identifiers

NCT03122353

TOL2708C

Details and patient eligibility

About

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.

Full description

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

Enrollment: 699 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

699 participants in 3 patient groups, including a placebo group

Calcipotriene Hydrate and Betamethasone

Experimental group

Description:

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Treatment:

Drug: Calcipotriene and betamethasone suspension

Taclonex

Active Comparator group

Description:

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Treatment:

Drug: Taclonex

Placebo

Placebo Comparator group

Description:

Topical suspension without active ingredient

Treatment:

Drug: Placebo