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

Phase 3

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Calcipotriene/Betamethasone Dipropionate; Drug: Placebo; Drug: Taclonex®

• Registration Number: NCT03331523
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriene/betamethasone dipropionate	Calcipotriene/Betamethasone Dipropionate	-
Placebo	Placebo	-
Taclonex®	Taclonex®	-

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (31)

Investigational Site 25; 🇺🇸 Las Vegas, Nevada, United States

Investigational Site 18; 🇺🇸 Fountain Inn, South Carolina, United States

Investigational Site 8; 🇺🇸 Nashville, Tennessee, United States

Investigational Site 27; 🇺🇸 Mount Pleasant, South Carolina, United States

Investigational Site 3; 🇺🇸 Fremont, California, United States

Investigational Site 9; 🇺🇸 Knoxville, Tennessee, United States

Investigational Site 23; 🇺🇸 Richmond, Virginia, United States

Investigational Site 24; 🇺🇸 Encinitas, California, United States

Investigational Site 13; 🇺🇸 San Diego, California, United States

Investigational Site 20; 🇺🇸 San Diego, California, United States

Investigational Site 14; 🇺🇸 Denver, Colorado, United States

Investigational Site 17; 🇺🇸 Henderson, Nevada, United States

Investigational Site 12; 🇺🇸 Fridley, Minnesota, United States

Investigational Site 1; 🇺🇸 Miami, Florida, United States

Investigational Site 30; 🇺🇸 Miami, Florida, United States

Investigational Site 15; 🇺🇸 New Albany, Indiana, United States

Investigational Site 21; 🇺🇸 Louisville, Kentucky, United States

Investigational Site 26; 🇺🇸 Saint Joseph, Missouri, United States

Investigational Site 16; 🇺🇸 San Antonio, Texas, United States

Investigational Site 29; 🇺🇸 Forest Hills, New York, United States

Investigational Site 11; 🇺🇸 College Station, Texas, United States

Investigational Site 19; 🇺🇸 San Antonio, Texas, United States

Investigational Site 31; 🇺🇸 Norfolk, Virginia, United States

Investigational Site 7; 🇺🇸 Miramar, Florida, United States

Investigational Site 22; 🇺🇸 Tampa, Florida, United States

Investigational Site 32; 🇺🇸 Santa Monica, California, United States

Investigational Site 10; 🇺🇸 South Bend, Indiana, United States

Investigational Site 6; 🇺🇸 Ann Arbor, Michigan, United States

Investigational Site 28; 🇺🇸 Rochester, New York, United States

Investigational Site 4; 🇺🇸 High Point, North Carolina, United States

Investigational Site 5; 🇺🇸 Austin, Texas, United States