NCT00418249

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

January 4, 2007

Status Verified

December 1, 2006

First QC Date

January 2, 2007

Last Update Submit

January 3, 2007

Conditions

Alopecia

Keywords

Androgenetic AlopeciaTelogen effluviumChronic telogen effluviumMenopauseFemale Androgenetic Alopecia (FAGA)

Outcome Measures

Primary Outcomes (1)

  • hair density

Secondary Outcomes (2)

  • Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,

  • Self-administered satisfaction questionnaire

Interventions

AS101DRUG

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Alopecia

Interventions

ammonium trichloro(dioxoethylene-O,O'-)tellurate

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Danny Ben-Amitai, M.D.

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Ben Amitai, MD

CONTACT

972-3-9253770

Raziel Lurie, MD

CONTACT

rlurie@bezeqint.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Last Updated

January 4, 2007

Record last verified: 2006-12

Locations

IL(1)