AlopeciaPhase 2NCT00418249
Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
A Phase 2 study testing AS101 in people with Alopecia, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Alopecia
- What is being tested?
- AS101
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women in menopause, over 50 years of age.
- Clinically diagnosed for AGA, according to Ludwig scale I-II.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Danny Ben Amitai, MD contact
Raziel Lurie, MD contact
About this study
Official title: 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.
- Conditions
- Alopecia
- Being tested
- AS101
- Keywords
- Androgenetic Alopecia, Telogen effluvium, Chronic telogen effluvium, Menopause, Female Androgenetic Alopecia (FAGA)
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Danny Ben-Amitai, M.D., Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418249
- Sponsor's protocol ID
- #69 REV 00
- Status last verified
- Dec 2006
- First submitted
- 2 Jan 2007
- Last updated
- 4 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
- ClinicalTrials.gov ID
- NCT00418249
- Acronym / sponsor ID
- #69 REV 00
- Conditions
- Alopecia
- Keywords
- Androgenetic Alopecia, Telogen effluvium, Chronic telogen effluvium, Menopause, Female Androgenetic Alopecia (FAGA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women in menopause, over 50 years of age.
- Clinically diagnosed for AGA, according to Ludwig scale I-II.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS101 | Drug | – |
Primary outcome
hair density
2 secondary outcomes
Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
Self-administered satisfaction questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Ben Amitai, MD contact
Raziel Lurie, MD contact
Danny Ben-Amitai, M.D. principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS101 in people with Alopecia, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Ben Amitai, MD (972-3-9253770), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair density. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2007.