Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

July 28, 2022 updated by: Galderma R&D

Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Study Type

Observational

Enrollment (Actual)

2488

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
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 76117
        • DHC Dimensional HealthCare, Inc. (Clinical Research Organization)

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

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

Inclusion Criteria:

  • Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
  • At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
  • History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion Criteria:

  • Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
  • Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
  • Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
Drug: Clobetasol Propionate, 0.05%
Apply twice daily for 2 or 4 weeks as monotherapy
Other Names:
  • Clobex® Spray, 0.05%
2
Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
Drug: Clobetasol propionate, 0.05% Spray
Apply twice daily for 2 or 4 weeks as add-on therapy
Other Names:
  • Clobex® Spray, 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Change in Target Plaque Severity rating
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
Time Frame: 4 weeks
4 weeks
Safety - Evaluation of adverse events and tolerability
Time Frame: 4 weeks
4 weeks

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

February 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

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

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US10029

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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