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

A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

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.

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: clobetasol propionate spray 0.05%; Drug: Vehicle spray

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • New York
    • New York, New York, United States, 10155
      • Research Division of The Skin Specialty Group
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clobex Spray	Drug: clobetasol propionate spray 0.05%; Apply enough product to cover affected areas topically twice daily at least 8 hours apart; Other Names: Clobex® Spray 0.05%
Placebo Comparator: Vehicle spray	Drug: Vehicle spray; Apply enough product to cover affected areas topically twice daily at least 8 hours apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and 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.	baseline to week 4
Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and 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.	baseline to week 4
Number of Participants in Each Category of Pruritus at Baseline and 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.	baseline to week 4

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: US10118