Psoriasis Clinical Trial
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
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.
Eligibility Criteria
Inclusion Criteria:
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.
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 (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.
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There are 31 Locations for this study
Encinitas California, 92024, United States
Fremont California, 94538, United States
San Diego California, 92108, United States
San Diego California, 92123, United States
Santa Monica California, 90404, United States
Denver Colorado, 80220, United States
Miami Florida, 33144, United States
Miami Florida, 33175, United States
Miramar Florida, 33027, United States
Tampa Florida, 33609, United States
New Albany Indiana, 47150, United States
South Bend Indiana, 46617, United States
Louisville Kentucky, 40241, United States
Ann Arbor Michigan, 48103, United States
Fridley Minnesota, 55432, United States
Saint Joseph Missouri, 64506, United States
Henderson Nevada, 89052, United States
Las Vegas Nevada, 89128, United States
Forest Hills New York, 11375, United States
Rochester New York, 14623, United States
High Point North Carolina, 27262, United States
Fountain Inn South Carolina, 29644, United States
Mount Pleasant South Carolina, 29464, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37215, United States
Austin Texas, 78759, United States
College Station Texas, 77845, United States
San Antonio Texas, 78213, United States
San Antonio Texas, 78249, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23294, United States
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