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

NCT ID: NCT00437255

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Same as above.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Clobex® Spray

Group Type ACTIVE_COMPARATOR

Clobetasol Propionate, 0.05%

Intervention Type DRUG

Topical, twice daily for 4 weeks

2

Taclonex® Ointment

Group Type ACTIVE_COMPARATOR

Calcipotriene and betamethasone dipropionate ointment

Intervention Type DRUG

Topical, once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clobetasol Propionate, 0.05%

Topical, twice daily for 4 weeks

Intervention Type DRUG

Calcipotriene and betamethasone dipropionate ointment

Topical, once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clobex® Spray Taclonex® Ointment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Galderma Laboratories, L.P.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma Laboratories, LP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

J & S Studies, Inc.

Bryan, Texas, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

US10034

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.