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

NCT00733954 | Completed Phase 4 Results

• 1 other identifier: US10012
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale

  Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)

  Baseline and Week 2 and Baseline and Week 4

Secondary Outcomes (18)

• Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale

  Baseline and Week 2

• Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale

  Baseline and Week 4 and Baseline and Week 6

• Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment

  Baseline and Week 2

• Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment

  Baseline and Week 2

• Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment

  Baseline and Week 2

Study Arms (2)

clobetasol propionate spray

ACTIVE COMPARATOR

clobetasol propionate spray 0.05%

Drug: clobetasol propionate spray

clobetasol propionate ointment

ACTIVE COMPARATOR

clobetasol propionate ointment 0.05%

Drug: clobetasol propionate ointment

Interventions

clobetasol propionate spray DRUG

Apply twice daily

Also known as: Clobex® Spray

clobetasol propionate spray

clobetasol propionate ointment DRUG

Apply twice daily

clobetasol propionate ointment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

East Bay Dermatology Medical Group, Inc.

Fremont, California, 94538, United States

Location

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Baylor Research Institute - Dermatology Research

Dallas, Texas, 75246, United States

Location

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 23, 2022
• Results First Posted: August 20, 2009

Record last verified: 2014-04

Locations

US (6)