Topical AS101 for Treatment of FAGA (Female Androgenetic... | NCT00418249

Studies
Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

NCT00418249

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jan 4, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Alopecia

Interventions

AS101

Countries

Israel

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

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 2, 2007

First Submission Date that Met QC Criteria

Jan 3, 2007

First Posted Date

Jan 4, 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

Jan 3, 2007

Last Update Posted Date

Jan 4, 2007Estimated

Description Module

Brief Summary

The primary objective of this study is to assess the safety and efficacy of topical AS101 as treatment for Female Androgenetic Alopecia (FAGA) in menopause women.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
AS101	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hair density

Secondary Outcomes

Measure	Description	Time Frame
Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
Self-administered satisfaction questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women in menopause, over 50 years of age.
Clinically diagnosed for AGA, according to Ludwig scale I-II.

Exclusion Criteria:

Women treated with chronic medications.
Use of Minoxidil within 3 months prior to entering study.
Women who have underwent hair transplantation.
Use of drugs with androgenic or anti-androgenic effects.
Any other type of hair loss.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Danny Ben Amitai, MD	Contact	972-3-9253770
Raziel Lurie, MD	Contact			rlurie@bezeqint.net

Overall Officials

Name	Affiliation	Role
Danny Ben-Amitai, M.D.	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tel Aviv			Israel	Danny Ben Amitai

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C054105	ammonium trichloro(dioxoethylene-O,O'-)tellurate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided