To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis
NCT ID: NCT03880357
Last Updated: 2019-03-19
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
485 participants
INTERVENTIONAL
2018-10-22
2019-03-15
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
QUADRUPLE
Study Groups
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Test Product
Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)
Betamethasone Scalp Suspension 0.064%;0.0005%
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Reference Product
Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)
Taclonex®
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Placebo
Vehicle of the test product (Taro Pharmaceuticals Inc.)
Placebo topical suspension
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Interventions
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Betamethasone Scalp Suspension 0.064%;0.0005%
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Taclonex®
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Placebo topical suspension
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
* Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
* A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp
Exclusion Criteria
* Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Yantovskiy
Role: STUDY_DIRECTOR
Taro Pharmaceuticals
Locations
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Catawba Research, LLC
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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BTCS 1614
Identifier Type: -
Identifier Source: org_study_id
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