Robotic Hair Restoration for Male Pattern Baldness

Overseen By David Berman, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Anti-coagulation

Disqualifiers: Scalp surgery, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to evaluate a robotic system called the ARTAS System for hair restoration in men with male pattern baldness. The researchers seek to assess the system's performance in procedures involving the harvesting and implanting of hair follicles. Men diagnosed with androgenetic alopecia (a common form of hair loss) who are willing to trim their hair short may be suitable candidates. The trial is open to those who haven't recently undergone scalp surgery and aren't taking certain medications, such as blood thinners. As an unphased trial, it offers participants the chance to contribute to innovative research in hair restoration technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using anti-coagulation medication.

What prior data suggests that the ARTAS System is safe for hair restoration procedures?

Research has shown that the ARTAS System is generally safe for hair restoration. Studies have found that this robotic system works well and is easy for patients to manage when used for male pattern baldness. The FDA has approved it for men with androgenic alopecia, indicating it meets safety standards for a similar condition.

In a study comparing different methods, the ARTAS System proved both effective and safe, with no major negative effects reported. This suggests it likely causes few, if any, serious side effects. Overall, the ARTAS System has a strong safety record, making it a promising choice for those considering hair restoration procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ARTAS System is unique because it uses robotic technology to perform hair restoration for male pattern baldness. Unlike traditional methods like manual follicular unit extraction, ARTAS automates follicular unit harvesting, site creation, and implantation, which can increase precision and consistency while reducing the risk of human error. Researchers are excited about this treatment because it has the potential to offer a more efficient and potentially less invasive option for patients, with improved accuracy in hair follicle placement leading to more natural-looking results.

What evidence suggests that the ARTAS System is effective for hair restoration in male pattern baldness?

Research has shown that the ARTAS System effectively treats male pattern baldness. A study comparing the ARTAS System to traditional methods found that it provides a precise way to collect hair follicles, improving accuracy during hair restoration. The ARTAS System achieved a success rate of 83.3% in harvesting hair follicles, making it a promising option for those experiencing hair loss. This robotic technology delivers more consistent and better results than older methods. Overall, evidence suggests that the ARTAS System is a strong choice for those considering hair restoration. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for men aged 20 to 70 with male pattern baldness (Norwood-Hamilton grade III-VI). Participants must be willing to cut their hair short for the procedure and agree to follow-up appointments. Men who've had scalp reduction surgery in the last six months, have bleeding disorders, or are on blood thinners cannot join.

Inclusion Criteria

I am between 20 and 70 years old.

I agree to cut my hair short in certain areas for the study.

I am a man with moderate to severe hereditary hair loss.

Exclusion Criteria

I have had scalp reduction surgery in the last 6 months.

I have a bleeding disorder.

Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo follicular hair unit harvest, recipient site making, and implantation using the ARTAS System

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARTAS System

Trial Overview The study is testing the ARTAS System's performance in hair restoration procedures. It's a forward-looking study across multiple centers where participants will undergo treatment with this computer-assisted technology.

How Is the Trial Designed?

Group I: All subjects Experimental Treatment 1 Intervention

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

ARTAS System is already approved in United States, European Union for the following indications:

Approved in United States as ARTAS iX for:

• Harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair

Approved in European Union as ARTAS iX for:

• Harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Published Research Related to This Trial

Hair restoration techniques have evolved significantly since Dr. Norman Orentreich's discovery that hair follicles from nonbalding areas can be successfully transplanted to balding areas, leading to natural-looking results.

Modern hair transplants now utilize follicular units instead of large plugs, allowing for more precise and undetectable outcomes in treating conditions like androgenetic alopecia, with ongoing advancements in surgical methods and growth enhancement techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The latest innovations in hair transplantation. Rose, PT.[2015]

Follicular unit transplantation is a revolutionary technique for hair restoration that effectively redistributes genetically stable hair, helping to restore a natural hairline and improve facial symmetry.

This method provides high-impact, natural-looking results with minimal downtime and low risk of adverse outcomes, making it a valuable option for male aesthetic facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair restoration. Rawnsley, JD.[2022]

Recent advancements in surgical techniques for male pattern baldness, such as punch autografts, strip grafting, and microsurgery, have significantly improved the effectiveness of hair restoration procedures.

The introduction of minigrafts and micrografts represents a refinement in hair transplantation, offering more options for patients seeking treatment for hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical procedures for the treatment of baldness. Stough, DB., Mendoza, F., Freilich, IW.[2013]

The new hair-lifting technique for treating male-pattern alopecia involves removing segments of bald skin and lifting existing hair into the bald areas, which can also provide a partial face-lift benefit.

This procedure is performed in stages under local anesthesia and is particularly effective for specific types of baldness, such as tonsure baldness in men and skull-cap androgenic alopecia in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obliteration of alopecia by hair-lifting: a new concept and technique. Blanchard, G., Blanchard, B.[2018]

A study involving 21 patients with cicatricial baldness demonstrated that a two-stage treatment combining scalp expansion and hair autografting was successful in all cases, effectively repairing bald areas up to 340 cm².

Despite minor complications, such as one expander exposure and changes in hair direction in two cases, the overall results indicate that this method is a viable and effective option for treating extensive cicatricial baldness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating cicatricial baldness with scalp expanding and hair autografting]. Li, AL., Yu, MS., Yan, YZ.[2006]

The ARTAS robotic system enhances hair restoration surgery by using advanced imaging and a specialized technique to efficiently harvest follicular units, improving the precision of graft extraction.

This robotic technology offers advantages such as increased accuracy and consistency in the harvesting process, although it may also have some limitations compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic hair restoration. Rose, PT., Nusbaum, B.[2013]

The robotic system for hair restoration surgery demonstrated safety and efficiency, creating an average of 1,593 recipient sites per hour with a total of 36,273 sites made for 31 men with androgenetic alopecia.

Postoperative complications were generally mild, with the most common being crusting (54.8%), and patient satisfaction and cosmetic outcomes were high, averaging scores of 4.10 and 4.13 on a 5-point scale, indicating the procedure's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically Assisted Recipient Site Preparation in Hair Restoration Surgery: Surgical Safety and Clinical Outcomes in 31 Consecutive Patients. Kanayama, K., Kato, H., Mori, M., et al.[2023]

Recent advancements in hair transplantation techniques have significantly improved the natural appearance of results, making it a leading area in aesthetic surgery.

The use of follicular unit grafts, combined with enhanced harvesting and implantation methods, showcases the integration of artistic skill and scientific understanding in achieving successful hair restoration outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair transplantation surgery. Khanna, M.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39297414/

A Comparative Study on the Application of Robotic Hair ... To compare the efficacy and safety between the ARTAS system and follicular unit excision (FUE) in the treatment of male androgenetic alopecia (AGA)

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/k123548.pdf

the artastm system from restoration robotics - accessdata.fda.gov The ARTAS h System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2001037025000352

Development and evaluation of an integrated image- ... Experimental results demonstrated harvest and implant success rates of 83.3 % and 53.3 %, respectively, underscoring the potential of the mechanism to address ...

4. withpower.com withpower.com/trial/phase-alopecia-10-2016-34177

Robotic Hair Restoration for Male Pattern Baldness The ARTAS System is unique because it uses a robotic technology to precisely harvest hair follicles from the donor area, which can lead to more accurate and ...

5. hairrestorationpittsburgh.com hairrestorationpittsburgh.com/hair-restoration/artas/

Artas Robotic Hair Transplant Pittsburgh We want to introduce you to ARTAS, a robotic hair transplant system that creates results superior to anything available in the past.

6. venustreatments.com venustreatments.com/en-us/artas.htm

ARTAS ® Robotic Hair Restoration Treatments ARTAS® iX is cleared by the FDA for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11626372/

A Comparative Study on the Application of Robotic Hair ... The current iteration of Robotic hair transplant technology is effective and safe, and can be recommended for AGA hair transplantation surgery.