TargetCool + Benev Exosomes for Alopecia
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.12345Why 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.14567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive four treatments over 9 weeks, which may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 and 6 months after the final treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exosomes
- Microneedling
- TargetCool
Find a Clinic Near You
Who Is Running the Clinical Trial?
Recens Medical, Inc.
Lead Sponsor
Benev Company, Inc.
Industry Sponsor