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

G

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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