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A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT00436540
Collaborator
(none)
78
Enrollment
2
Locations
2
Arms
10.1
Duration (Months)
39
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.

Condition or Disease Intervention/Treatment Phase
  • Drug: Clobetasol Propionate 0.05% Spray
  • Drug: Clobetasol Propionate 0.05% Foam
 Phase 4

Detailed Description

Same as above.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

clobetasol propionate (Clobex®) spray

Drug: Clobetasol Propionate 0.05% Spray
Apply to affected areas twice daily
Other Names:
  • Clobex® Spray

    		•
    Active Comparator: 2

    clobetasol propionate (Olux®) foam

    Drug: Clobetasol Propionate 0.05% Foam
    Apply to affected areas twice daily
    Other Names:
  • Olux® Foam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy - Body Surface Area, Investigator Global Severity [6 weeks]

    Secondary Outcome Measures

    1. Safety - Tolerability assessments, adverse events [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved
    Exclusion Criteria:

    • Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® spray or more than 50 grams per week of Olux® foam

    • Subjects whose psoriasis involves the scalp, face or groin

    • Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Solano Clinical Research Vallejo California United States 94589
    2 Central Dermatology, PC Saint Louis Missouri United States 63117

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    • Study Director: Ronald W. Gottschalk, MD, Galderma Laboratories, LP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00436540
    Other Study ID Numbers:
    • US10013
    First Posted:
    Feb 19, 2007
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Psoriasis
    Clobetasol

    Study Results

    No Results Posted as of Jul 29, 2022