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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

643

Study ID:

NCT03331523

Recruitment Status:

Completed

Sponsor:

Glenmark Pharmaceuticals Ltd. India

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There are 31 Locations for this study

See Locations Near You

Investigational Site 24
Encinitas California, 92024, United States
Investigational Site 3
Fremont California, 94538, United States
Investigational Site 13
San Diego California, 92108, United States
Investigational Site 20
San Diego California, 92123, United States
Investigational Site 32
Santa Monica California, 90404, United States
Investigational Site 14
Denver Colorado, 80220, United States
Investigational Site 1
Miami Florida, 33144, United States
Investigational Site 30
Miami Florida, 33175, United States
Investigational Site 7
Miramar Florida, 33027, United States
Investigational Site 22
Tampa Florida, 33609, United States
Investigational Site 15
New Albany Indiana, 47150, United States
Investigational Site 10
South Bend Indiana, 46617, United States
Investigational Site 21
Louisville Kentucky, 40241, United States
Investigational Site 6
Ann Arbor Michigan, 48103, United States
Investigational Site 12
Fridley Minnesota, 55432, United States
Investigational Site 26
Saint Joseph Missouri, 64506, United States
Investigational Site 17
Henderson Nevada, 89052, United States
Investigational Site 25
Las Vegas Nevada, 89128, United States
Investigational Site 29
Forest Hills New York, 11375, United States
Investigational Site 28
Rochester New York, 14623, United States
Investigational Site 4
High Point North Carolina, 27262, United States
Investigational Site 18
Fountain Inn South Carolina, 29644, United States
Investigational Site 27
Mount Pleasant South Carolina, 29464, United States
Investigational Site 9
Knoxville Tennessee, 37922, United States
Investigational Site 8
Nashville Tennessee, 37215, United States
Investigational Site 5
Austin Texas, 78759, United States
Investigational Site 11
College Station Texas, 77845, United States
Investigational Site 16
San Antonio Texas, 78213, United States
Investigational Site 19
San Antonio Texas, 78249, United States
Investigational Site 31
Norfolk Virginia, 23507, United States
Investigational Site 23
Richmond Virginia, 23294, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

643

Study ID:

NCT03331523

Recruitment Status:

Completed

Sponsor:


Glenmark Pharmaceuticals Ltd. India

How clear is this clinincal trial information?

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