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

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcipotriene and betamethasone suspension
Taclonex
Placebo
Sponsored by
Tolmar Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 17
  • Site 29
  • Site 12
  • Site 18
  • Site 34
  • Site 20
  • Site 01
  • Site 25
  • Site 11
  • Site 26
  • Site 04
  • Site 05
  • Site 02
  • Site 03
  • Site 23
  • Site 16
  • Site 19
  • Site 33
  • Site 27
  • Site 14
  • Site 09
  • Site 28
  • Site 24
  • Site 32
  • Site 07
  • Site 35
  • Site 21
  • Site 06
  • Site 30
  • Site 08
  • Site 15
  • Site 31
  • Site 10
  • Site 22

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Calcipotriene Hydrate and Betamethasone

Taclonex

Placebo

Arm Description

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Topical suspension without active ingredient

Outcomes

Primary Outcome Measures

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.
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.
Body Surface Area (BSA)
To evaluate the total body area of skin affected by psoriasis.
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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2017
Last Updated
March 5, 2018
Sponsor
Tolmar Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03122353
Brief Title
BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
Official Title
A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tolmar Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
699 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcipotriene Hydrate and Betamethasone
Arm Type
Experimental
Arm Description
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Arm Title
Taclonex
Arm Type
Active Comparator
Arm Description
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical suspension without active ingredient
Intervention Type
Drug
Intervention Name(s)
Calcipotriene and betamethasone suspension
Other Intervention Name(s)
Calcipotriene, betamethasone
Intervention Description
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Intervention Type
Drug
Intervention Name(s)
Taclonex
Other Intervention Name(s)
Calcipotriene, betamethasone
Intervention Description
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
vehicle used as placebo
Primary Outcome Measure Information:
Title
Psoriasis Area Severity Index (PASI)
Description
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.
Time Frame
at Day 1, Day 28
Title
Physician Global Assessment (PGA)
Description
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.
Time Frame
at Day 1, Day 28
Title
Body Surface Area (BSA)
Description
To evaluate the total body area of skin affected by psoriasis.
Time Frame
at Day 1
Title
Adverse Events and Serious Adverse Events
Description
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
Time Frame
at Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Joffrion
Organizational Affiliation
Catawba Research
Official's Role
Study Director
Facility Information:
Facility Name
Site 17
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Site 29
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Site 12
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Site 18
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Site 34
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Site 20
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Site 01
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Site 25
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 11
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site 26
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Site 04
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Site 05
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Site 02
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Site 03
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Site 23
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Site 16
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Site 19
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Site 33
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Site 27
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Site 14
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Site 09
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 28
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Site 24
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Site 32
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Site 07
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Site 35
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site 21
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Site 06
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Site 30
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Site 08
City
Murphy
State/Province
Texas
ZIP/Postal Code
75094
Country
United States
Facility Name
Site 15
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 31
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 10
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Site 22
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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