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Trial record 27 of 272 for:    Betamethasone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331523
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

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 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.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: Calcipotriene/Betamethasone Dipropionate Drug: Taclonex® Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 643 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018


Arm Intervention/treatment
Experimental: Calcipotriene/betamethasone dipropionate Drug: Calcipotriene/Betamethasone Dipropionate
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)

Active Comparator: Taclonex® Drug: Taclonex®
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331523


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Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Investigators
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Study Director: William Todd Kays Glenmark Pharmaceuticals Inc., USA

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Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT03331523     History of Changes
Other Study ID Numbers: GLK-1701
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents