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”

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.

Study Type: Observational

Study Design: Case-Only, Other

Study Primary Completion Date: July 2006

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
• : 2
  • Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment

Primary Measures

• Efficacy - Change in Target Plaque Severity rating
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
  • Time Frame: 4 weeks
    Safety Issue?: No
• Safety - Evaluation of adverse events and tolerability
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437216

Study ID Number: US10029

ClinicalTrials.gov Identifier: NCT00437216

Health Authority: United States: Institutional Review Board