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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:October 22, 2018
End Date:March 15, 2019

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Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis

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.

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

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
We found this trial at
1
site
5200 77 Center Drive
Charlotte, North Carolina 28217
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from
Charlotte, NC
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