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

Sun Pharmaceutical Industries, Inc.485 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

485

Conditions

Scalp Psoriasis

Interventions

Betamethasone Scalp Suspension 0.064%;0.0005%DRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Taclonex®DRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Placebo topical suspensionDRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Catawba Research, LLC

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

treatment success on the Physician's Global Assessment (PGA) of disease severity

The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity

Time frame: Study Week 4 (Day 28 ± 4 days)

clinical success on the Physician's Global Assessment (PASI) of disease severity

The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.

Time frame: Study Week 4 (Day 28 ± 4 days)

Data from ClinicalTrials.gov

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