Psoriasis Clinical Trial

To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

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Full Description

Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

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Eligibility Criteria

Inclusion Criteria:

Healthy male or non-pregnant female aged ≥18 years
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:

Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
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

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

485

Study ID:

NCT03880357

Recruitment Status:

Completed

Sponsor:

Taro Pharmaceuticals USA

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There is 1 Location for this study

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Catawba Research, LLC
Charlotte North Carolina, 28217, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

485

Study ID:

NCT03880357

Recruitment Status:

Completed

Sponsor:


Taro Pharmaceuticals USA

How clear is this clinincal trial information?

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