A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam

Galderma

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Clobetasol Propionate 0.05% Spray; Drug: Clobetasol Propionate 0.05% Foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436540

US10013

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.

Full description

Same as above.

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved

Exclusion criteria

• Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® spray or more than 50 grams per week of Olux® foam
• Subjects whose psoriasis involves the scalp, face or groin
• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

1

Active Comparator group

Description:

clobetasol propionate (Clobex®) spray

Treatment:

Drug: Clobetasol Propionate 0.05% Spray

2

Active Comparator group

Description:

clobetasol propionate (Olux®) foam

Treatment:

Drug: Clobetasol Propionate 0.05% Foam