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

Completed · Phase 3 · Has a placebo group

Conditions studied: Scalp Psoriasis

In brief

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.

Key facts

Study ID

NCT03331523

Run by

Glenmark Pharmaceuticals Ltd. India

People needed

643

Starts

2017-10-20

Expected to finish

2018-10-25

Last updated by the study team

2018-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
• 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.
• A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
• 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.

You may not qualify if…

• 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 (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
• Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
• Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
• History of psoriasis unresponsive to topical treatments.
• Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Where it is running

• Investigational Site 24 — Encinitas, California, United States
• Investigational Site 3 — Fremont, California, 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 14 — Denver, Colorado, 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 22 — Tampa, Florida, United States
• Investigational Site 15 — New Albany, Indiana, United States
• Investigational Site 10 — South Bend, Indiana, United States
• Investigational Site 21 — Louisville, Kentucky, United States
• Investigational Site 6 — Ann Arbor, Michigan, United States
• Investigational Site 12 — Fridley, Minnesota, United States
• Investigational Site 26 — Saint Joseph, Missouri, United States
• Investigational Site 17 — Henderson, Nevada, United States
• Investigational Site 25 — Las Vegas, Nevada, United States
• Investigational Site 29 — Forest Hills, New York, United States
• Investigational Site 28 — Rochester, New York, United States
• Investigational Site 4 — High Point, North Carolina, United States
• Investigational Site 18 — Fountain Inn, South Carolina, United States
• Investigational Site 27 — Mt. Pleasant, South Carolina, United States
• Investigational Site 9 — Knoxville, Tennessee, United States
• Investigational Site 8 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.