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

Completed

• Conditions: Psoriasis
• Interventions: Drug: Clobetasol Propionate, 0.05%; Drug: Clobetasol propionate, 0.05% Spray

• Registration Number: NCT00437216
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-17
• Study First Posted: 2007-02-19
• Status Verified: 2008-03
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2488

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Clobetasol Propionate, 0.05%	Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
2	Clobetasol propionate, 0.05% Spray	Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment

Primary Outcome Measures

Name	Time	Method
Efficacy - Change in Target Plaque Severity rating	4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety - Evaluation of adverse events and tolerability	4 weeks
Efficacy - Self-Assessment of Quality of Life, Subject satisfaction	4 weeks

Trial Locations

Locations (1)

DHC Dimensional HealthCare, Inc. (Clinical Research Organization); 🇺🇸 Cedar Knolls, New Jersey, United States