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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Scalp Psoriasis

Treatments: Drug: Taclonex®; Drug: Calcipotriene/Betamethasone Dipropionate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03331523

GLK-1701

Details and patient eligibility

About

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.

Enrollment: 643 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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643 participants in 3 patient groups, including a placebo group

Calcipotriene/betamethasone dipropionate

Experimental group

Treatment:

Drug: Calcipotriene/Betamethasone Dipropionate

Taclonex®

Active Comparator group

Treatment:

Drug: Taclonex®

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo