Phase 4 N=249 Randomized Treatment

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

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT00733954 ↗

Enrolled (actual)

249

Serious AEs

0.0%

Results posted

Aug 2009

Primary outcome: Primary: 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 — 62; 44 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: clobetasol propionate spray (Drug); clobetasol propionate ointment (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	62; 44	—
SECONDARY 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	39; 44	—
SECONDARY 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	50; 33	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment	29; 33	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment	53; 72	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment	48; 52	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment	53; 33	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment	73; 72	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment	72; 52	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment	48; 32	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment	56; 43	—
SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment	55; 35	—
SECONDARY Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment	28.6; 35.9	—
SECONDARY Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment	29.1; 38.4	—
SECONDARY Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment	51; 35.9	—
SECONDARY Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment	52; 38.4	—
SECONDARY Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment	48; 37.6	—
SECONDARY Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment	48.6; 38.3	—
SECONDARY Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment	1; 0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00733954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.