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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

  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

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

31

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Data sourced from clinicaltrials.gov

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