Back to resultsTopical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
Primary Purpose
Alopecia
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
AS101
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia focused on measuring Androgenetic Alopecia, Telogen effluvium, Chronic telogen effluvium, Menopause, Female Androgenetic Alopecia (FAGA)
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.
Sites / Locations
Outcomes
Primary Outcome Measures
hair density
Secondary Outcome Measures
Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
Self-administered satisfaction questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00418249
Brief Title
Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
Official Title
Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
Androgenetic Alopecia, Telogen effluvium, Chronic telogen effluvium, Menopause, Female Androgenetic Alopecia (FAGA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AS101
Primary Outcome Measure Information:
Title
hair density
Secondary Outcome Measure Information:
Title
Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
Title
Self-administered satisfaction questionnaire
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny Ben Amitai, MD
Phone
972-3-9253770
First Name & Middle Initial & Last Name or Official Title & Degree
Raziel Lurie, MD
Email
rlurie@bezeqint.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Ben-Amitai, M.D.
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Ben Amitai
Phone
972-3-9253770
12. IPD Sharing Statement
Learn more about this trial
Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
We'll reach out to this number within 24 hrs