Status:
COMPLETED
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Conditions:
Scalp Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT03331523
Start Date
October 20 2017
End Date
October 25 2018
Last Update
December 21 2018
Active Locations (31)
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1
Investigational Site 24
Encinitas, California, United States, 92024
2
Investigational Site 3
Fremont, California, United States, 94538
3
Investigational Site 13
San Diego, California, United States, 92108
4
Investigational Site 20
San Diego, California, United States, 92123