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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Scalp Psoriasis

Treatments: Drug: Betamethasone Scalp Suspension 0.064%;0.0005%; Drug: Taclonex®; Drug: Placebo topical suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT03880357

BTCS 1614

Details and patient eligibility

About

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.

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

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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485 participants in 3 patient groups, including a placebo group

Test Product

Experimental group

Description:

Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Betamethasone Scalp Suspension 0.064%;0.0005%

Reference Product

Active Comparator group

Description:

Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)

Treatment:

Drug: Taclonex®

Placebo

Placebo Comparator group

Description:

Vehicle of the test product (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Placebo topical suspension