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BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension 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: NCT03122353
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Tolmar Inc.

Study Description
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Brief Summary:
This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: Calcipotriene and betamethasone suspension Drug: Taclonex Drug: Placebo Phase 1

Detailed Description:
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Calcipotriene Hydrate and Betamethasone
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
 Drug: Calcipotriene and betamethasone suspension
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Other Name: Calcipotriene, betamethasone
Active Comparator: Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
 Drug: Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Other Name: Calcipotriene, betamethasone
Placebo Comparator: Placebo
Topical suspension without active ingredient
 Drug: Placebo
vehicle used as placebo
Other Name: Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: at Day 1, Day 28 ]
    To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.

  2. Physician Global Assessment (PGA) [ Time Frame: at Day 1, Day 28 ]
    To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.

  3. Body Surface Area (BSA) [ Time Frame: at Day 1 ]
    To evaluate the total body area of skin affected by psoriasis.

  4. Adverse Events and Serious Adverse Events [ Time Frame: at Day 28 ]
    Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis


Eligibility Criteria
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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:

  • Male or non-pregnant, non-lactating female, at least 18 years of age.
  • Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
  • 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.
  • Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
  • Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
  • Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose > 400 IU/day during the study.
  • Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
  • Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.

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 (eg, atopic dermatitis, contact dermatitis, tinea capitis).
  • History of hypersensitivity to any component of TEST or RLD.
  • Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.
Contacts and Locations
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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): NCT03122353


Locations
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Sponsors and Collaborators
Tolmar Inc.
Investigators
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Study Director: Jim Joffrion Catawba Research
More Information
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Responsible Party: Tolmar Inc.
ClinicalTrials.gov Identifier: NCT03122353    
Other Study ID Numbers: TOL2708C
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 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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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Calcipotriene
Betamethasone sodium phosphate
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