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

NCT00881868 | Completed Phase 4 Results

• 1 other identifier: US10118
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

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.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Extent of Scalp Involvement Index at Baseline and Week 4

  baseline to week 4

• Number of Participants in Each Category of Pruritus at Baseline and Week 4

  baseline to week 4

Study Arms (2)

Clobex Spray

ACTIVE COMPARATOR

Drug: clobetasol propionate spray 0.05%

Vehicle spray

PLACEBO COMPARATOR

Drug: Vehicle spray

Interventions

clobetasol propionate spray 0.05% DRUG

Apply enough product to cover affected areas topically twice daily at least 8 hours apart

Also known as: Clobex® Spray 0.05%

Clobex Spray

Vehicle spray DRUG

Apply enough product to cover affected areas topically twice daily at least 8 hours apart

Vehicle spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Research Division of The Skin Specialty Group

New York, New York, 10155, United States

Location

Dermatology Associates, PLLC

Seattle, Washington, 98101, United States

Location

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 25, 2022
• Results First Posted: December 23, 2010

Record last verified: 2012-09

Locations

US (4)