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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

August 11, 2008
April 28, 2014
August 2007
April 2008   (final data collection date for primary outcome measure)
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)
Overall Disease Severity at end of treatment [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00733954 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 ]
Not Provided
Not Provided
 
Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis
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

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.

Same as above.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: clobetasol propionate spray
    Apply twice daily
    Other Name: Clobex® Spray
  • Drug: clobetasol propionate ointment
    Apply twice daily
    Other Name: clobetasol propionate ointment
  • Active Comparator: clobetasol propionate spray
    clobetasol propionate spray 0.05%
    Intervention: Drug: clobetasol propionate spray
  • Active Comparator: clobetasol propionate ointment
    clobetasol propionate ointment 0.05%
    Intervention: Drug: clobetasol propionate ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733954
US10012
No
Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
Not Provided
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP