Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Galderma R&D305 enrolled

Overview

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Same as above.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

305

Conditions

Psoriasis

Interventions

clobetasol propionate spray 0.05%DRUG

clobetasol propionate spray, 0.05%, applied topically twice daily

calcitriol ointmentDRUG

calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area * Overall Disease Severity of at least 3 (moderate) Exclusion Criteria: * Surface area involvement too large (\>20% BSA) * Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Locations (12)

Therapeutics Clinical Research

San Diego, California, United States

MedaPhase, Inc.

Newnan, Georgia, United States

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, United States

Outcomes

Primary Outcomes

Overall Disease Severity Success (ODS)

Success was defined as a one-grade improvement in ODS from baseline.

Time frame: 8 and 12 weeks