Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

Galderma

Status: Completed

Conditions: Psoriasis

Treatments: Drug: Clobetasol propionate, 0.05% Spray; Drug: Clobetasol Propionate, 0.05%

Study type: Observational

Funder types: Industry

Identifiers

NCT00437216

US10029

Details and patient eligibility

About

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

Full description

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Enrollment: 2,488 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
• At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
• History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion criteria

• Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
• Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
• Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits

Trial design

2,488 participants in 2 patient groups

1

Description:

Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®

Treatment:

Drug: Clobetasol Propionate, 0.05%

2

Description:

Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment

Treatment:

Drug: Clobetasol propionate, 0.05% Spray