Evaluation of Eflornithine on Facial and Forearm Skin | NCT00152048

Studies
Evaluation of Eflornithine on Facial and Forearm Skin

NCT00152048

Sponsor

Allergan

Status

Completed

Last Update Posted

Oct 30, 2019Actual

Enrollment

Phase

Phase 4

Conditions

Hirsutism

Interventions

Eflornithine hydrochloride

Countries

Not provided

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

ID	Type	Description	Link
2004-000726-78	EudraCT Number

Status Module

Record Verification Date

Oct 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 30, 2004Actual

Primary Completion Date

Not provided

Completion Date

Oct 31, 2005Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 9, 2005Estimated

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

Oct 28, 2019

Last Update Posted Date

Oct 30, 2019Actual

Description Module

Brief Summary

The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Eflornithine hydrochloride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Skin biopsies
Histology and histochemistry in the dermis
Physician Global Assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
Women of childbearing potential must agree to use an effective form of birth control for the duration of the study
Skin type I-IV
Customary frequency of removal of facial hair two or more times per week

Exclusion Criteria:

Pregnant or lactating women
Severe inflammatory acne or presence of significant scarring on the face
History of skin malignancy
Connective tissue disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006628	Hirsutism

Ancestor Terms

ID	Term
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D014770	Virilism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000518	Eflornithine

Ancestor Terms

ID	Term
D009952	Ornithine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided