TargetCool + Benev Exosomes for Alopecia

Overseen By Jen Clinical Program Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Recens Medical, Inc.

Must not be taking: Anti-androgens, Hormones, 5-alpha-reductase

Disqualifiers: Pregnancy, Hair transplant, Uncontrolled diseases, others

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

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to addressing hair thinning by combining several cosmetic treatments. Researchers are testing whether exosomes (tiny particles from stem cells that may promote hair growth), microneedling (a technique using small needles to enhance skin absorption), and TargetCool™ (a cooling device that reduces inflammation) can work together for improved results. The study seeks healthy men and women experiencing hair thinning who have not changed their hair loss treatments in the past year. Participants will be divided into groups to receive different combinations of these treatments over nine weeks, with follow-ups to assess improvements. The goal is to determine if this combination is safe and effective for enhancing hair health. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for hair thinning.

Will I have to stop taking my current medications?

You don't have to stop your current medications, but you should not start any new hair loss treatments or change your medications during the study. If your doctor advises you to change your medications, you need to inform the clinic right away.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that exosomes are generally safe for medical treatments. In one study, researchers reported no negative side effects when using an Exosome Regenerative Complex with microneedling to promote hair growth. Participants expressed high satisfaction with the treatment. However, more research is needed to fully confirm the safety and effectiveness of exosomes for treating hair thinning.

Research indicates that TargetCool™, a device that precisely cools the skin, is safe and effective for various medical procedures. The FDA has approved it, confirming it meets safety standards for its intended uses. The device quickly cools the skin, reducing swelling and improving comfort.

Overall, previous studies suggest these treatments are well-tolerated. However, ongoing research is essential to fully understand their safety for hair thinning. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for alopecia because they utilize exosomes, which are tiny particles that can help stimulate hair growth by delivering growth factors directly to the scalp. Unlike traditional treatments like minoxidil or finasteride, which primarily work by prolonging the hair growth phase or blocking hormones, these exosome treatments offer a new approach by potentially enhancing scalp health and encouraging natural hair regrowth. Additionally, the use of TargetCool technology in combination with exosomes is unique because it may enhance the effectiveness of the treatment by cooling the scalp, which can reduce inflammation and increase comfort during application. This innovative method holds promise for those seeking alternatives to current hair loss treatments.

What evidence suggests that this trial's treatments could be effective for hair thinning?

This trial will evaluate different combinations of treatments for alopecia. One arm will use microneedling to a depth of 0.5mm followed by Benev exosome topical application. Another arm will use TargetCool with a Benev exosome Boost. A third arm will combine microneedling followed by TargetCool Boosting with Benev exosome. Research has shown that combining exosome therapy with microneedling can aid hair regrowth. Studies have found that exosomes, which contain growth-promoting substances, can increase hair thickness and improve patient satisfaction. In one study, hair thickness improved significantly after using exosomes. Microneedling, when paired with exosomes, enhances scalp absorption, boosting the effects. TargetCool™, which reduces swelling, may further enhance these benefits. Overall, these combinations appear promising for individuals experiencing hair thinning. ^{1 4 5 6 7}

Who Is on the Research Team?

Dawn Queen, MD

Principal Investigator

Marc Avram, MD

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for healthy men aged 18-70 and women around 45-70 who are not of childbearing potential, experiencing hair thinning. Participants must be willing to undergo cosmetic treatments including microneedling and application of exosomes with or without a cooling device.

Inclusion Criteria

I am willing to undergo scalp treatments with TargetCool or microneedling followed by exosome application.

Subjects willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible

I am a healthy male aged 18-70 or a female aged 45-70 not able to have children.

Exclusion Criteria

Subjects who are of child-bearing age, pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study

I have had a hair transplant.

I have been on a stable dose of birth control or hormone replacement therapy for 3+ months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four treatments over 9 weeks, which may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment

9 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 and 6 months after the final treatment

32 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exosomes
• Microneedling
• TargetCool

Trial Overview The study tests the effectiveness of combining exosomes (particles from stem cells) with a precision cooling device (TargetCool™) and microneedling on scalp health. It's divided into three groups: one receiving just exosomes, another adding TargetCool™, and the third using both plus microneedling.

How Is the Trial Designed?

Group I: Microneedling to depth of 0.5mm followed by Benev exosome topical Active Control 3 Interventions

Group II: Microneedling followed by TargetCool Boosting with Benev exosome Active Control 4 Interventions

Group III: TargetCool with Benev exosome Boost Active Control 3 Interventions

Who Is Running the Clinical Trial?

Recens Medical, Inc.

Lead Sponsor

Trials

2

Recruited

120+

Benev Company, Inc.

Industry Sponsor

Trials

3

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06999408?term=AREA%5BConditionSearch%5D(%22Hair%20Diseases%22)&rank=4

Efficacy and Safety of TargetCool + Benev Exosomes in ... This clinical trial is testing a new approach to help improve hair thinning using a combination of cosmetic treatments. The purpose of the study is to learn ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588828/

Effectiveness of Exosome Treatment in Androgenetic ... Foreskin-derived mesenchymal stromal cells derived exosome injection increased hair density, with sustained patient satisfaction throughout the study.

3. jddonline.com jddonline.com/articles/an-exosome-regenerative-complex-plus-microneedling-promotes-hair-growth-in-subjects-with-self-perceived-thinning-hair-S1545961625P9244X

An Exosome Regenerative Complex Plus Microneedling ... These results suggest exosome therapy combined with microneedling is a beneficial treatment for AGA. An innovative technology separates and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624002241

Review Exploring the reality of exosomes in dermatology In a randomized, double-blind, placebo-controlled study, the topical application of PMSC-exos after microneedling showed good results in skin quality. The 20 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06571799

NCT06571799 | Study Evaluating the Efficacy and Safety of ... Exosomes can provide effective treatment for skin rejuvenation, scar reduction, hyperpigmentation, and hair growth. This new technology can be used alone but ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12305264/

Therapeutic potential of stem cell-derived exosomes in hair ... Study evaluating the efficacy and safety of BENEV exosome regenerative complex+ for self-perceived thinning hair ... Examining the Uncertainties ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jocd.15008

Exosome therapy in hair regeneration: A literature review ... Clinical trials demonstrate safety of exosome use in medicine, but data showing efficacy and safety of exosome therapy for alopecia are lacking.