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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00437216

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Clobetasol Propionate, 0.05% Drug: Clobetasol propionate, 0.05% Spray	Phase IV

Study Type:	Observational
Study Design:	Case-Only
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Efficacy - Change in Target Plaque Severity rating [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy - Self-Assessment of Quality of Life, Subject satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Safety - Evaluation of adverse events and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	2488
Study Start Date:	February 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®	Drug: Clobetasol Propionate, 0.05% Apply twice daily for 2 or 4 weeks as monotherapy
2 Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment	Drug: Clobetasol propionate, 0.05% Spray Apply twice daily for 2 or 4 weeks as add-on therapy

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community Sample

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437216

Locations

United States, New Jersey
DHC Dimensional HealthCare, Inc. (Clinical Research Organization)
Cedar Knolls, New Jersey, United States, 76117

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, LP

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10029
Study First Received:	February 16, 2007
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00437216 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009