Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)

NYU Langone Health

Status: Withdrawn

Conditions: Alopecia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06497764

24-00472

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Procedure: PRP Treatment

Device: Vibrational Anesthesia (VA) Device

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

Experimental group

Description:

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.

Treatment:

Procedure: PRP Treatment

Device: Vibrational Anesthesia (VA) Device