Pivotal Bioequivalence Study of Topically Delivered Clobe... | NCT00864500

Studies
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

NCT00864500

Sponsor

Actavis Inc.

Status

Completed

Last Update Posted

Jul 9, 2019Actual

Enrollment

224Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Clobetasol Propionate 0.05% lotion, single exposure
Clobex TM 0.05% Lotion, single exposure

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

Jul 2019

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

Nov 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Mar 17, 2009

First Submission Date that Met QC Criteria

Mar 17, 2009

First Posted Date

Mar 18, 2009Estimated

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 8, 2019

Last Update Posted Date

Jul 9, 2019Actual

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

To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

Detailed Description

Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.

Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Clobetasol Propionate 0.05% lotion, single exposure	Drug: Clobetasol Propionate 0.05% lotion, single exposure
B	Active Comparator	Clobex TM 0.05% Lotion, single exposure	Drug: Clobex TM 0.05% Lotion, single exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clobetasol Propionate 0.05% lotion, single exposure	Drug	A: Experimental Subjects received Alpharma USPD, Inc formulated products	A

Measure	Description	Time Frame
Vasoconstrictor Response		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
Signed and dated informed consent form which meets all criteria of current FDA regulations.

Exclusion Criteria:

History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
Presence of a medical condition requiring regular treatment with prescription drugs.
Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
Use of any tobacco products in the 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
Pregnant or lactating.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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