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 |
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.
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
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
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