NCT00437255

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 29, 2022

Status Verified

April 1, 2008

Enrollment Period

10 months

First QC Date

February 16, 2007

Last Update Submit

July 28, 2022

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Overall Disease Severity

    End of treatment (Week 4)

  • Tolerability assessments, incidence of adverse events

    Baseline, Weeks 1, 2, 4 and 8

Secondary Outcomes (2)

  • Overall Disease Severity

    Weeks 1, 2 and 8

  • Investigator Global Assessment

    End of treatment (week 4) and Weeks 1, 2 and 8

Study Arms (2)

1

ACTIVE COMPARATOR

Clobex® Spray

Drug: Clobetasol Propionate, 0.05%

2

ACTIVE COMPARATOR

Taclonex® Ointment

Drug: Calcipotriene and betamethasone dipropionate ointment

Interventions

Clobetasol Propionate, 0.05%DRUG

Topical, twice daily for 4 weeks

Also known as: Clobex® Spray
1
Calcipotriene and betamethasone dipropionate ointmentDRUG

Topical, once daily

Also known as: Taclonex® Ointment
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

Bryan, Texas, 77802, United States

Location

Baylor Research Institute

Dallas, Texas, 75230, United States

Location

MeSH Terms

Interventions

Clobetasolcalcipotriene

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ronald W Gottschalk, MD

    Galderma Laboratories, LP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

August 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

July 29, 2022

Record last verified: 2008-04

Locations

US(4)