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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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