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

January 3, 2007 updated by: Rabin Medical Center

Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
hair density

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Danny Ben-Amitai, M.D., Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #69 REV 00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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