Androgenic AlopeciaNCT05938569
Computer-Assisted Hair Restoration Study Using ARTAS System
A study testing Hair restoration in people with Androgenic Alopecia, run by Venus Concept at 2 sites in United States.
Trial summary
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Hair restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2016to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
- Subject is 20 to 70 years old
- Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
- Subject is able to understand and provide written consent
- Subject consents to post-operative follow-up per protocol
Who cannot join
- Subject has prior history of scalp reduction surgery(s) in the past six months
- Subject has bleeding diathesis
- Subject has active use of anti-coagulation medication
- Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
Berman Skin Institute
Los Altos, California, 94022
- Recruiting
Le's Aesthetics
San Jose, California, 95112
Vincent Le, D.O., 408-835-9977, vle02@yahoo.com
Lin Phong, 408-835-9977, infohaircenters@gmail.com
About this study
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
- Conditions
- Androgenic Alopecia
- Being tested
- Hair restoration
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair restorationDevice
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation. Receives: Device: Hair restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Measured: 1 year post-treatment
Secondary outcomes (1)
Percentage of follicles successfully harvested by Robot
Measured: 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start3 Nov 2016
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938569
- Sponsor's protocol ID
- CP-017
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Hair Restoration Study Using ARTAS System
- ClinicalTrials.gov ID
- NCT05938569
- Acronym / sponsor ID
- CP-017
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 10 Jul 2023 (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.
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Hair restorationThe Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
- Subject is 20 to 70 years old
- Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
- Subject is able to understand and provide written consent
- Subject consents to post-operative follow-up per protocol
Key exclusion criteria (4 listed)
- Subject has prior history of scalp reduction surgery(s) in the past six months
- Subject has bleeding diathesis
- Subject has active use of anti-coagulation medication
- Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
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 restorationThe Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation. | Device | All subjects |
Primary outcome
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Time frame: 1 year post-treatment
1 secondary outcome
Percentage of follicles successfully harvested by Robot
Time frame: 1 year post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair restoration in people with Androgenic Alopecia, run by Venus Concept at 2 sites in United States.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Clinical Affairs, PhD (8889070115, mgronski@venusconcept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation (time frame: 1 year post-treatment). 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 26 Aug 2024.