Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)

NCT ID: NCT06497764

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control (PRP Alone), then Intervention (PRP with VA)

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.

Group Type EXPERIMENTAL

Vibrational Anesthesia (VA) Device

Intervention Type DEVICE

The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.

PRP Treatment

Intervention Type PROCEDURE

PRP (a needle-related procedure) will be delivered per routine standard of care.

Intervention (PRP with VA), then Control (PRP Alone)

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 Type EXPERIMENTAL

Vibrational Anesthesia (VA) Device

Intervention Type DEVICE

The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.

PRP Treatment

Intervention Type PROCEDURE

PRP (a needle-related procedure) will be delivered per routine standard of care.

Interventions

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Vibrational Anesthesia (VA) Device

The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.

Intervention Type DEVICE

PRP Treatment

PRP (a needle-related procedure) will be delivered per routine standard of care.

Intervention Type PROCEDURE

Other Intervention Names

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Buzzy bee-striped personal

Eligibility Criteria

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Inclusion Criteria

* Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
* Able to participate in study procedures.
* Able to provide consent.

Exclusion Criteria

* Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
* Patients unable to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen Lo Sicco

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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24-00472

Identifier Type: -

Identifier Source: org_study_id

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