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NCT00418249 Clinical Trial

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

Alopecia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00418249
Other study ID # #69 REV 00
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received January 2, 2007
Last updated January 3, 2007

Study information
Verified date December 2006
Source Rabin Medical Center
Contact Danny Ben Amitai, MD
Phone 972-3-9253770
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AS101

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary hair density
Secondary Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
Secondary Self-administered satisfaction questionnaire
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