BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: Calcipotriene and betamethasone suspension; Drug: Taclonex; Drug: Placebo

Detailed Description

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

• Study Type: Interventional
• Enrollment (Actual): 699
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Site 17
  • California
    • Fremont, California, United States, 94538
      • Site 29
    • Los Angeles, California, United States, 90036
      • Site 12
    • Sherman Oaks, California, United States, 91403
      • Site 18
  • Colorado
    • Denver, Colorado, United States, 80220
      • Site 34
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Site 20
    • Brandon, Florida, United States, 33511
      • Site 01
    • Coral Gables, Florida, United States, 33134
      • Site 25
    • Hialeah, Florida, United States, 33012
      • Site 11
    • Miami, Florida, United States, 33126
      • Site 26
    • Miami, Florida, United States, 33175
      • Site 04
    • Miramar, Florida, United States, 33027
      • Site 05
    • Tampa, Florida, United States, 33609
      • Site 02
    • Tampa, Florida, United States, 33618
      • Site 03
    • Winter Park, Florida, United States, 32792
      • Site 23
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Site 16
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Site 19
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Site 33
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Site 27
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Site 14
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 09
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Site 28
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Site 24
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Site 32
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Site 07
    • Mount Pleasant, South Carolina, United States, 29464
      • Site 35
  • Texas
    • Austin, Texas, United States, 78759
      • Site 21
    • Dallas, Texas, United States, 75234
      • Site 06
    • El Paso, Texas, United States, 79902
      • Site 30
    • Murphy, Texas, United States, 75094
      • Site 08
    • San Antonio, Texas, United States, 78229
      • Site 15
    • San Antonio, Texas, United States, 78229
      • Site 31
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Site 10
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Site 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Calcipotriene, betamethasone
Placebo Comparator: Placebo; Topical suspension without active ingredient	Drug: Placebo; vehicle used as placebo; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area Severity Index (PASI)	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.	at Day 1, Day 28
Physician Global Assessment (PGA)	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.	at Day 1, Day 28
Body Surface Area (BSA)	To evaluate the total body area of skin affected by psoriasis.	at Day 1
Adverse Events and Serious Adverse Events	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	at Day 28

Collaborators and Investigators

• Sponsor: Tolmar Inc.
• Investigators: Study Director: Jim Joffrion, Catawba Research

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Calcitriol
• Other Study ID Numbers: TOL2708C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No