Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis - Full Text View

Sponsored by:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00733954

Purpose

This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: clobetasol propionate spray Drug: clobetasol propionate ointment	Phase IV

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis

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

Primary Outcome Measures:

Overall Disease Severity at end of treatment [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Disease Severity after 2 weeks of treatment and at 2 weeks post indicated treatment (week 4 for clobetasol propionate ointment group and week 6 for clobetasol propionate spray group) [ Time Frame: 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
Signs of Psoriasis after two weeks of treatment, end of treatment, and at two weeks post treatment [ Time Frame: 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in body surface area (%BSA affected and treated) after two weeks of treatment, end of treatment and at two weeks post treatment [ Time Frame: 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
Tolerability assessments and adverse events [ Time Frame: 4 weeks and 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	250
Study Start Date:	August 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator clobetasol propionate spray	Drug: clobetasol propionate spray Apply twice daily
2: Active Comparator clobetasol propionate ointment	Drug: clobetasol propionate ointment Apply twice daily

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
Subjects whose psoriasis involves only the scalp, face or groin
Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733954

Locations

United States, California
East Bay Dermatology Medical Group, Inc.
Fremont, California, United States, 94538
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Texas
Baylor Research Institute - Dermatology Research
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10012
Study First Received:	August 11, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00733954 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Hormone Antagonists

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

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 May 07, 2009