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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00733954
First received: August 11, 2008
Last updated: April 28, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 after 2 weeks of treatment

  • 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 [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment

  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment

  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment

  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)

  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)

  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment

  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment

  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)

  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
    Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)

  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)

  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
    Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)

  • Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: Yes ]
    Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)


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
Active Comparator: clobetasol propionate spray
clobetasol propionate spray 0.05%
Drug: clobetasol propionate spray
Apply twice daily
Other Name: Clobex® Spray
Active Comparator: clobetasol propionate ointment
clobetasol propionate ointment 0.05%
Drug: clobetasol propionate ointment
Apply twice daily
Other Name: clobetasol propionate ointment

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
ClinicalTrials.gov Identifier: NCT00733954     History of Changes
Other Study ID Numbers: US10012
Study First Received: August 11, 2008
Results First Received: April 30, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014