BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
NCT ID: NCT03122353
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
699 participants
INTERVENTIONAL
2017-04-11
2017-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Calcipotriene Hydrate and Betamethasone
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Calcipotriene and betamethasone suspension
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Placebo
Topical suspension without active ingredient
Placebo
vehicle used as placebo
Interventions
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Calcipotriene and betamethasone suspension
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Placebo
vehicle used as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Tolmar Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jim Joffrion
Role: STUDY_DIRECTOR
Catawba Research
Locations
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Site 17
Hot Springs, Arkansas, United States
Site 29
Fremont, California, United States
Site 12
Los Angeles, California, United States
Site 18
Sherman Oaks, California, United States
Site 34
Denver, Colorado, United States
Site 20
Boca Raton, Florida, United States
Site 01
Brandon, Florida, United States
Site 25
Coral Gables, Florida, United States
Site 11
Hialeah, Florida, United States
Site 26
Miami, Florida, United States
Site 04
Miami, Florida, United States
Site 05
Miramar, Florida, United States
Site 02
Tampa, Florida, United States
Site 03
Tampa, Florida, United States
Site 23
Winter Park, Florida, United States
Site 16
Plainfield, Indiana, United States
Site 19
Olathe, Kansas, United States
Site 33
Lake Charles, Louisiana, United States
Site 27
Saint Joseph, Missouri, United States
Site 14
Las Vegas, Nevada, United States
Site 09
High Point, North Carolina, United States
Site 28
Hazleton, Pennsylvania, United States
Site 24
Upper Saint Clair, Pennsylvania, United States
Site 32
Johnston, Rhode Island, United States
Site 07
Anderson, South Carolina, United States
Site 35
Mt. Pleasant, South Carolina, United States
Site 21
Austin, Texas, United States
Site 06
Dallas, Texas, United States
Site 30
El Paso, Texas, United States
Site 08
Murphy, Texas, United States
Site 15
San Antonio, Texas, United States
Site 31
San Antonio, Texas, United States
Site 10
Salt Lake City, Utah, United States
Site 22
Norfolk, Virginia, United States
Countries
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Other Identifiers
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TOL2708C
Identifier Type: -
Identifier Source: org_study_id
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