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

July 28, 2022 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Same as above.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Vallejo, California, United States, 94589
        • Solano Clinical Research
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Body Surface Area, Investigator Global Severity
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety - Tolerability assessments, adverse events
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 16, 2007

First Submitted That Met QC Criteria

February 16, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US10013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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