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

Scalp Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122353
• Other study ID #: TOL2708C
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2017
• Last updated: March 5, 2018
• Start date: April 11, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: March 2018
• Source: Tolmar Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• Calcipotriene and betamethasone suspension
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
• Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
• Placebo
vehicle used as placebo

Locations

Country	Name	City	State
United States	Site 07	Anderson	South Carolina
United States	Site 21	Austin	Texas
United States	Site 20	Boca Raton	Florida
United States	Site 01	Brandon	Florida
United States	Site 25	Coral Gables	Florida
United States	Site 06	Dallas	Texas
United States	Site 34	Denver	Colorado
United States	Site 30	El Paso	Texas
United States	Site 29	Fremont	California
United States	Site 28	Hazleton	Pennsylvania
United States	Site 11	Hialeah	Florida
United States	Site 09	High Point	North Carolina
United States	Site 17	Hot Springs	Arkansas
United States	Site 32	Johnston	Rhode Island
United States	Site 33	Lake Charles	Louisiana
United States	Site 14	Las Vegas	Nevada
United States	Site 12	Los Angeles	California
United States	Site 04	Miami	Florida
United States	Site 26	Miami	Florida
United States	Site 05	Miramar	Florida
United States	Site 35	Mount Pleasant	South Carolina
United States	Site 08	Murphy	Texas
United States	Site 22	Norfolk	Virginia
United States	Site 19	Olathe	Kansas
United States	Site 16	Plainfield	Indiana
United States	Site 27	Saint Joseph	Missouri
United States	Site 10	Salt Lake City	Utah
United States	Site 15	San Antonio	Texas
United States	Site 31	San Antonio	Texas
United States	Site 18	Sherman Oaks	California
United States	Site 02	Tampa	Florida
United States	Site 03	Tampa	Florida
United States	Site 24	Upper Saint Clair	Pennsylvania
United States	Site 23	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tolmar Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area Severity Index (PASI)	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.	at Day 1, Day 28
Primary	Physician Global Assessment (PGA)	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.	at Day 1, Day 28
Primary	Body Surface Area (BSA)	To evaluate the total body area of skin affected by psoriasis.	at Day 1
Primary	Adverse Events and Serious Adverse Events	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	at Day 28