Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

July 28, 2022 updated by: Galderma R&D

An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis

Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Same as above.

Study Type

Interventional

Enrollment (Actual)

122

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
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Bryan, Texas, United States, 77802
        • J & S Studies, Inc.
      • Dallas, Texas, United States, 75230
        • Baylor Research Institute

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:

  • Moderate to severe psoriasis involving 3-20% of the body surface area

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 100 grams per week of Taclonex® Ointment
  • Subjects having psoriasis that involves the scalp, face, or groin

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Clobex® Spray
Drug: Clobetasol Propionate, 0.05%
Topical, twice daily for 4 weeks
Other Names:
  • Clobex® Spray
ACTIVE_COMPARATOR: 2
Taclonex® Ointment
Drug: Calcipotriene and betamethasone dipropionate ointment
Topical, once daily
Other Names:
  • Taclonex® Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Disease Severity
Time Frame: End of treatment (Week 4)
End of treatment (Week 4)
Tolerability assessments, incidence of adverse events
Time Frame: Baseline, Weeks 1, 2, 4 and 8
Baseline, Weeks 1, 2, 4 and 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Disease Severity
Time Frame: Weeks 1, 2 and 8
Weeks 1, 2 and 8
Investigator Global Assessment
Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8
End of treatment (week 4) and Weeks 1, 2 and 8

Collaborators and Investigators

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

Sponsor

Galderma R&D

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

August 1, 2006

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

February 16, 2007

First Submitted That Met QC Criteria

February 17, 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

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US10034

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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