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

Phase 1

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Placebo; Drug: Calcipotriene and betamethasone suspension; Drug: Taclonex

• Registration Number: NCT03122353
• Lead Sponsor: Tolmar Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-04-06
• Study Start: 2017-04-11
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 699

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Topical suspension without active ingredient
Calcipotriene Hydrate and Betamethasone	Calcipotriene and betamethasone suspension	Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Taclonex	Taclonex	Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Primary Outcome Measures

Name	Time	Method
Adverse Events and Serious Adverse Events	at Day 28	Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis
Physician Global Assessment (PGA)	at Day 1, Day 28	To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
Psoriasis Area Severity Index (PASI)	at Day 1, Day 28	To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
Body Surface Area (BSA)	at Day 1	To evaluate the total body area of skin affected by psoriasis.

Trial Locations

Locations (34)

Site 17; 🇺🇸 Hot Springs, Arkansas, United States

Site 29; 🇺🇸 Fremont, California, United States

Site 12; 🇺🇸 Los Angeles, California, United States

Site 18; 🇺🇸 Sherman Oaks, California, United States

Site 34; 🇺🇸 Denver, Colorado, United States

Site 20; 🇺🇸 Boca Raton, Florida, United States

Site 01; 🇺🇸 Brandon, Florida, United States

Site 25; 🇺🇸 Coral Gables, Florida, United States

Site 11; 🇺🇸 Hialeah, Florida, United States

Site 26; 🇺🇸 Miami, Florida, United States

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