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

NCT ID: NCT00436540

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Same as above.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

clobetasol propionate (Clobex®) spray

Group Type ACTIVE_COMPARATOR

Clobetasol Propionate 0.05% Spray

Intervention Type DRUG

Apply to affected areas twice daily

2

clobetasol propionate (Olux®) foam

Group Type ACTIVE_COMPARATOR

Clobetasol Propionate 0.05% Foam

Intervention Type DRUG

Apply to affected areas twice daily

Interventions

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Clobetasol Propionate 0.05% Spray

Apply to affected areas twice daily

Intervention Type DRUG

Clobetasol Propionate 0.05% Foam

Apply to affected areas twice daily

Intervention Type DRUG

Other Intervention Names

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Clobex® Spray Olux® Foam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Galderma Laboratories, L.P.

Principal Investigators

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Ronald W. Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma Laboratories, LP

Locations

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Solano Clinical Research

Vallejo, California, United States

Site Status

Central Dermatology, PC

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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US10013

Identifier Type: -

Identifier Source: org_study_id

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