Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)

NCT06497764 | Withdrawn FDA Device

• 1 other identifier: 24-00472
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure

  At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels.

  End of procedure (About 10 minutes, Day 1)

Secondary Outcomes (1)

• Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm

  Day 1

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Vibrational Anesthesia (VA) Device; Procedure: PRP Treatment

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

EXPERIMENTAL

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.

Device: Vibrational Anesthesia (VA) Device; Procedure: PRP Treatment

Interventions

Vibrational Anesthesia (VA) Device 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.

Also known as: Buzzy bee-striped personal

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

PRP Treatment PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristen Lo Sicco

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Kristen.losicco@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)