Vibrational Anesthesia for Alopecia

Overseen By Kristen Lo Sicco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Missing data, Unable to consent

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce pain during platelet-rich plasma (PRP) therapy, a common hair loss treatment. It compares the use of vibrational anesthesia (VA) on one half of the scalp to no anesthesia on the other half to determine if it reduces pain. Eligible participants must have undergone at least one PRP treatment for hair loss. Participants will rate their pain to help researchers assess the effectiveness of the VA device, which uses vibrations to reduce pain. This could lead to a more comfortable experience for those undergoing PRP treatments. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain-reduction methods in PRP therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the vibrational anesthesia device is safe for use in this study?

Research shows that vibrational anesthesia (VA) is generally safe during medical procedures. Studies have found that a vibrating device can significantly reduce pain without side effects. For example, one study found that patients experienced much less pain with vibration than without it. Another study highlighted that vibrational anesthesia is simple to use and does not cause complications.

Overall, evidence suggests that vibrational anesthesia is well-tolerated and safe for pain reduction during treatments. This should reassure anyone considering joining a trial using this technique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrational Anesthesia (VA) for alopecia because it introduces a novel technique to potentially enhance the effectiveness of standard Platelet-Rich Plasma (PRP) treatments. Unlike traditional PRP therapy, which involves injecting platelets into the scalp to stimulate hair growth, VA incorporates a vibrational device during the procedure. This vibration may improve the absorption and effectiveness of PRP by enhancing blood flow and reducing discomfort during injections. By potentially increasing the efficacy and comfort of PRP treatments, VA could represent a significant advancement in alopecia care.

What evidence suggests that the Vibrational Anesthesia device is effective for reducing pain during PRP treatment for alopecia?

Research has shown that vibrational anesthesia (VA), which participants in this trial may receive, can greatly reduce pain during procedures. One study found that about 95% of patients experienced less pain. VA is a safe and easy method to reduce discomfort. It doesn't involve surgery and has few side effects, making it a popular choice for pain reduction in skin treatments. The evidence supports that VA effectively lessens pain, making treatments more comfortable for patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Kristen Lo Sicco

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients at the NYU Skin and Cancer Clinic or Faculty Group Practice with alopecia areata, a type of hair loss. Participants will be part of one study group where half their scalp gets vibrational anesthesia (VA) during PRP treatment.

Inclusion Criteria

I have had at least one PRP treatment on my scalp.

Able to provide consent

I can follow the study's required procedures.

Exclusion Criteria

I am unable to give consent by myself.

All my personal and treatment details are fully documented.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive PRP treatment with and without vibrational anesthesia on different halves of the scalp

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrational Anesthesia (VA) Device

Trial Overview The study tests if using a VA device can reduce pain compared to no anesthesia on the other half of the scalp during PRP treatments for hair loss. Patients' pain levels will be measured through surveys.

How Is the Trial Designed?

Group I: Intervention (PRP with VA), then Control (PRP Alone) Experimental Treatment 2 Interventions

Participants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone.

Group II: Control (PRP Alone), then Intervention (PRP with VA) Experimental Treatment 2 Interventions

Participants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Vibration anesthesia, using inexpensive massagers, effectively reduces discomfort during various dermatologic and cosmetic procedures, including botulinum toxin injections and laser therapies.

While vibration anesthesia may not completely eliminate pain, it significantly enhances the tolerability of injections, making it a valuable option for patients who are averse to needles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Smith, KC., Comite, SL., Balasubramanian, S., et al.[2022]

Thirteen FDA-cleared home-use photobiomodulation devices for treating androgenetic alopecia were identified, showing a variety of designs and features, but no direct comparisons of their efficacy exist.

These devices have an excellent safety profile and growing evidence of effectiveness, although more long-term studies are needed to confirm their efficacy across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. Dodd, EM., Winter, MA., Hordinsky, MK., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150760/

Vibration assisted analgesia during intralesional ... We present data demonstrating that vibration assisted analgesia, is a safe, effective and easy to use technique, which minimises pain from ICT.

2. jcadonline.com jcadonline.com/vibration-anesthesia-during-invasive-procedures-a-meta-analysis/

Vibration Anesthesia During Invasive Procedures: A Meta- ... About 95 percent of patients reported a significant reduction in their symptoms of pain, with notably zero patients recording an absence of pain when treated ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16480

Evaluating the efficacy of local anesthetic techniques ... The study involved a group of 62 men between the age of 20 and 50 with features of androgenetic alopecia who underwent three MN treatments. A ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11495163/

Vibration Anesthesia During Invasive Procedures: A Meta- ... Vibration anesthesia is a non-invasive, inexpensive, virtually side-effect free, and well-established method of lessening pain during dermatologic procedures.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0365059623000533

Female-pattern hair loss: therapeutic update Studies in both sexes showed that LLLT would be a well-tolerated therapy with no reported adverse effects. From an effectiveness point-of-view, most of the time ...

6. researchgate.net researchgate.net/publication/342792775_Use_of_vibrating_anesthetic_device_reduces_the_pain_of_mesotherapy_injections_A_randomized_split-scalp_study

(PDF) Use of vibrating anesthetic device reduces the pain ... To reduce pain in patients undergoing scalp mesotherapy, non-pharmacological options such as vibration anesthesia devices were considered safe, effective, and ...