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OpenTrials
Completed

NCT Number: NCT03331523

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site 24, Encinitas, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcipotriene/Betamethasone Dipropionate

Drug

Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)

Taclonex®

Drug

Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)

Placebo

Drug

Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)

Primary outcomes

  1. Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.

    Time frame: Day 29

  2. Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.

    Time frame: Day 29

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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