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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the Vibrational Anesthesia (VA) Device treatment for alopecia?

Research shows that using vibration anesthesia can significantly reduce pain during scalp injections, as seen in a study where patients reported much lower pain scores when a vibrating device was used. This suggests that the Vibrational Anesthesia Device could make treatments for alopecia more comfortable by reducing pain during procedures. ^{1 2 3 4 5}

Is vibrational anesthesia safe for use in humans?

Vibrational anesthesia has been used safely in various medical procedures, such as dermatology and dentistry, to reduce pain during injections and other treatments. It generally makes procedures more tolerable without eliminating pain completely, and no significant safety concerns have been reported. ^{1 2 4 6 7}

What is the purpose of this trial?

This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.

Research Team

Kristen Lo Sicco

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

I can follow the study's required procedures.

Able to provide consent

Exclusion Criteria

I am unable to give consent by myself.

All my personal and treatment details are fully documented.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of vibrating anesthetic device reduces the pain of mesotherapy injections: A randomized split-scalp study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous implantation of valproic acid-encapsulated dissolving microneedles induces hair regrowth. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Parallel Vibrating Kinetic Anesthesia Devices to Reduce Pain with Scalp Injections. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Buzzing away the pain: Using an electric toothbrush for vibration anesthesia during painful procedures. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Topical valproic acid increases the hair count in male patients with androgenetic alopecia: a randomized, comparative, clinical feasibility study using phototrichogram analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. [2018]