NCT00436540

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

2 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

March 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2 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
Last Updated

July 29, 2022

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

February 16, 2007

Last Update Submit

July 28, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Efficacy - Body Surface Area, Investigator Global Severity

    6 weeks

Secondary Outcomes (1)

  • Safety - Tolerability assessments, adverse events

    6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

clobetasol propionate (Clobex®) spray

Drug: Clobetasol Propionate 0.05% Spray

2

ACTIVE COMPARATOR

clobetasol propionate (Olux®) foam

Drug: Clobetasol Propionate 0.05% Foam

Interventions

Clobetasol Propionate 0.05% SprayDRUG

Apply to affected areas twice daily

Also known as: Clobex® Spray
1
Clobetasol Propionate 0.05% FoamDRUG

Apply to affected areas twice daily

Also known as: Olux® Foam
2

Eligibility Criteria

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

You may qualify if:

  • Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Central Dermatology, PC

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

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

March 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

July 29, 2022

Record last verified: 2008-03

Locations

US(2)