BENEV Exosome Regenerative Complex+ for Hair Loss

Overseen By Shelley Joyce, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ablon Skin Institute Research Center

Must not be taking: Rogaine, Nioxin, Finasteride, others

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: 5

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of BENEV Exosome Regenerative Complex+ following a microneedling procedure for thinning hair. The goal is to determine if this combination can enhance hair thickness and quality over four months. Ideal participants are healthy men and women experiencing hair thinning without a diagnosed condition like telogen effluvium. Participants will receive monthly treatments and must maintain their usual hair care routine throughout the study. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new solutions for hair thinning.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not substantially change your current medications during the study. If your doctor advises you to change your medications, you must inform the clinic as soon as possible.

What prior data suggests that BENEV Exosome Regenerative Complex+ is safe for use with SylFirmX® RF microneedling?

Research has shown that the BENEV Exosome Regenerative Complex+, when combined with RF microneedling, is generally well-tolerated. Studies have found this combination effective and free from significant side effects for individuals with thinning hair. Participants in these studies did not report major negative effects, indicating the treatment's safety for scalp use. However, individual experiences may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BENEV Exosome Regenerative Complex+ for hair loss because it uses exosomes, which are tiny, naturally occurring vesicles that can promote hair growth by delivering growth factors and signals directly to hair follicles. Unlike traditional treatments like minoxidil or finasteride, which often take months to show results and have varying effectiveness, this treatment is applied post-microneedling to enhance the absorption and efficacy of the exosomes. This novel approach might offer faster and more targeted hair regeneration, potentially leading to quicker and more noticeable improvements in hair density and quality.

What evidence suggests that BENEV Exosome Regenerative Complex+ might be an effective treatment for hair loss?

Research has shown that BENEV Exosome Regenerative Complex+ may improve hair growth and quality. In one study, 97% of participants noticed better hair quality, and 83% saw noticeable hair growth by day 120. Another study found a small but significant increase in hair density, from 149.7 to 153.6 hairs per square centimeter, after four weeks. These results suggest that using this complex, especially with microneedling, could benefit those with thinning hair. Overall, early evidence supports its potential to enhance hair thickness and appearance. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-65 who feel their hair is thinning. Participants will undergo a treatment combining BENEV Exosome Regenerative Complex+ with SylFirmX® RF microneedling monthly for four months, followed by a check-up.

Inclusion Criteria

Subjects must be in general good health as determined by the Investigator

Subjects must maintain consistent hair length, cut, style, and color throughout the study period

I am willing and able to fill out and understand questionnaires.

Exclusion Criteria

I have a medical condition that is not currently under control.

I have a diagnosed hair loss condition.

I can communicate and cooperate with my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BENEV Exosome Regenerative Complex+ post SylFirmX RF microneedling procedure applied to the scalp monthly for 4 sessions

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BENEV Exosome Regenerative Complex+

Trial Overview The study tests the effectiveness and safety of BENEV Exosome Regenerative Complex+ when used after SylFirmX® RF microneedling in treating self-perceived thinning hair. It requires four monthly treatments plus follow-up.

How Is the Trial Designed?

Group I: BENEV Exosome Regenerative Complex+ Experimental Treatment 1 Intervention

BENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure applied to the scalp monthly for 4 sessions.

Who Is Running the Clinical Trial?

Ablon Skin Institute Research Center

Lead Sponsor

Trials

8

Recruited

370+

Benev Company, Inc.

Industry Sponsor

Trials

3

Recruited

130+

Citations

1. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41037530/

An Exosome Regenerative Complex Plus Microneedling ... On day 120, the investigator rating for improved hair quality was 97% and improved hair growth was 83%. Subject satisfaction with treatment ...

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 ... On day 120, the investigator rating for improved hair quality was 97% and improved hair growth was 83%. Subject satisfaction with treatment ...

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329855/

Advances in the extracellular vesicles treatment of alopecia The mean hair density increased from 149.7 ± 13.7 hairs/cm2 at pre-treatment to 153.6 ± 16.8 hairs/cm2 at the 4th week (p = 0.043) and further ...

6. ctv.veeva.com ctv.veeva.com/study/study-evaluating-the-efficacy-and-safety-of-benev-exosome-regenerative-complex-for-self-perceived-t

Study Evaluating the Efficacy and Safety of BENEV Exosome ... The goal of this clinical trial is to further substantiate the effectiveness and safety of BENEV Exosome Regenerative Complex+ post ...