A Comparison Between Clobetasol Propionate 0.05% (Clobex®... | NCT00436540

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

NCT00436540

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

78Actual

Phase

Phase 4

Conditions

Psoriasis

Interventions

Clobetasol Propionate 0.05% Spray
Clobetasol Propionate 0.05% Foam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Feb 16, 2007

First Submission Date that Met QC Criteria

Feb 16, 2007

First Posted Date

Feb 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2022

Last Update Posted Date

Jul 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Same as above.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clobetasol Propionate 0.05% Spray	Drug	Apply to affected areas twice daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy - Body Surface Area, Investigator Global Severity		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety - Tolerability assessments, adverse events		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald W. Gottschalk, MD	Galderma Laboratories, LP	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Solano Clinical Research		Vallejo	California	94589	United States
Central Dermatology, PC

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002990	Clobetasol

Ancestor Terms

ID	Term
D001623	Betamethasone
D013259	Steroids, Fluorinated
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided