Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

Phase 4

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Vehicle spray; Drug: clobetasol propionate spray 0.05%

• Registration Number: NCT00881868
• Lead Sponsor: Galderma R&D

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-16
• Results First Submitted QC: 2010-12-16
• Results First Posted: 2010-12-23
• Status Verified: 2012-09
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion Criteria

• Subjects who need systemic treatment for their body psoriasis
• Subjects who have surface area involvement too large (>20% Body Surface Area [BSA]) that would require more than 50 grams per week of study product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle spray	Vehicle spray	-
Clobex Spray	clobetasol propionate spray 0.05%	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)	baseline to week 4	Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).

Secondary Outcome Measures

Name	Time	Method
Number of Participants in Each Category of Pruritus at Baseline and Week 4	baseline to week 4	Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4	baseline to week 4	Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4	baseline to week 4	Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = \<20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.

Trial Locations

Locations (4)

Hudson Dermatology; 🇺🇸 Evansville, Indiana, United States

Dermatology Associates, PLLC; 🇺🇸 Seattle, Washington, United States

Research Division of The Skin Specialty Group; 🇺🇸 New York, New York, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States