Hair LossNCT03652701
Hair Up Prospective Study
A study testing Hair Up in people with Hair Loss, run by Shmuel Gonen Technologies Ltd..
Trial summary
The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Loss
- What is being tested?
- Hair Up
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Mar 2021
- Phase
- Interventional
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who report hair loss during the past 3 months prior to the study
Who cannot join
- Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia
About this study
The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study
- Conditions
- Hair Loss
- Being tested
- Hair Up, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair UpOther
Herbal topical
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Hair Up | Experimental | Not described Receives: Other: Hair Up |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hair loss
Pull test
Measured: 1 month
Secondary outcomes (2)
Assessment of hair regrowth
Photographic evaluation of the change in hair density according to the Savin score (scale of 1-mild to 9-severe)
Measured: 3 months
Quality of life questionnaire
Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Why it stopped: sponsor discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shmuel Gonen Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652701
- Sponsor's protocol ID
- CLPR-001-0002
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Up Prospective Study
- ClinicalTrials.gov ID
- NCT03652701
- Acronym / sponsor ID
- CLPR-001-0002
- Conditions
- Hair Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shmuel Gonen Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 29 Aug 2018 (actual)
- 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 objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hair Up | Experimental | Other: Hair Up |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who report hair loss during the past 3 months prior to the study
Key exclusion criteria (1 listed)
- Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia
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 |
|---|---|---|
| Hair UpHerbal topical | Other | Hair Up |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Assessment of hair loss
Time frame: 1 month
Pull test
2 secondary outcomes
Assessment of hair regrowth
Time frame: 3 months
Quality of life questionnaire
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hair Up in people with Hair Loss, run by Shmuel Gonen Technologies Ltd..
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hair loss (time frame: 1 month). 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 Apr 2019.