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

Psoriasis Clinical Trial

Official title:

Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437216
• Other study ID #: US10029
• Status: Completed
• Start date: February 2006
• Est. completion date: July 2006

Study information

• Verified date: March 2008
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2488
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Clobetasol Propionate, 0.05%
Apply twice daily for 2 or 4 weeks as monotherapy
• Clobetasol propionate, 0.05% Spray
Apply twice daily for 2 or 4 weeks as add-on therapy

Locations

Country	Name	City	State
United States	DHC Dimensional HealthCare, Inc. (Clinical Research Organization)	Cedar Knolls	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Change in Target Plaque Severity rating		4 weeks
Secondary	Efficacy - Self-Assessment of Quality of Life, Subject satisfaction		4 weeks
Secondary	Safety - Evaluation of adverse events and tolerability		4 weeks