To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

Scalp Psoriasis Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331523
• Other study ID #: GLK-1701
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2017
• Est. completion date: October 25, 2018

Study information

• Verified date: December 2018
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.

2. 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.

3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade = 3).

4. A plaque elevation of at least moderate severity (Grade = 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.

2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).

3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.

4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.

5. History of psoriasis unresponsive to topical treatments.

6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• Calcipotriene/Betamethasone Dipropionate
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
• Taclonex®
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
• Placebo
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)

Locations

Country	Name	City	State
United States	Investigational Site 6	Ann Arbor	Michigan
United States	Investigational Site 5	Austin	Texas
United States	Investigational Site 11	College Station	Texas
United States	Investigational Site 14	Denver	Colorado
United States	Investigational Site 24	Encinitas	California
United States	Investigational Site 29	Forest Hills	New York
United States	Investigational Site 18	Fountain Inn	South Carolina
United States	Investigational Site 3	Fremont	California
United States	Investigational Site 12	Fridley	Minnesota
United States	Investigational Site 17	Henderson	Nevada
United States	Investigational Site 4	High Point	North Carolina
United States	Investigational Site 9	Knoxville	Tennessee
United States	Investigational Site 25	Las Vegas	Nevada
United States	Investigational Site 21	Louisville	Kentucky
United States	Investigational Site 1	Miami	Florida
United States	Investigational Site 30	Miami	Florida
United States	Investigational Site 7	Miramar	Florida
United States	Investigational Site 27	Mount Pleasant	South Carolina
United States	Investigational Site 8	Nashville	Tennessee
United States	Investigational Site 15	New Albany	Indiana
United States	Investigational Site 31	Norfolk	Virginia
United States	Investigational Site 23	Richmond	Virginia
United States	Investigational Site 28	Rochester	New York
United States	Investigational Site 26	Saint Joseph	Missouri
United States	Investigational Site 16	San Antonio	Texas
United States	Investigational Site 19	San Antonio	Texas
United States	Investigational Site 13	San Diego	California
United States	Investigational Site 20	San Diego	California
United States	Investigational Site 32	Santa Monica	California
United States	Investigational Site 10	South Bend	Indiana
United States	Investigational Site 22	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.		Day 29
Primary	Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.		Day 29