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

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol

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