Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

Galderma

Status and phase: Completed; Phase 4

Conditions: Scalp Psoriasis

Treatments: Drug: clobetasol propionate spray 0.05%; Drug: Vehicle spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881868

US10118

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion criteria

• Subjects who need systemic treatment for their body psoriasis
• Subjects who have surface area involvement too large (>20% Body Surface Area [BSA]) that would require more than 50 grams per week of study product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

Clobex Spray

Active Comparator group

Treatment:

Drug: clobetasol propionate spray 0.05%

Vehicle spray

Placebo Comparator group

Treatment:

Drug: Vehicle spray