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Behavioural Intervention

Vibrational Anesthesia for Alopecia

N/A

Waitlist Available

Led By Kristen Lo Sicco

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of

Be older than 18 years old

Must not have

Patients unable to consent

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of procedure (about 10 minutes, day 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll 100 patients at NYU Skin and Cancer Clinic to test a new method of pain relief during a platelet rich plasma (PRP) procedure. Patients will have half of their

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive VA and standard PRP therapy, side effects may include discomfort from the device vibration or typical reactions to PRP like scalp tenderness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent by myself.

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All my personal and treatment details are fully documented.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of procedure (about 10 minutes, day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of procedure (about 10 minutes, day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of procedure (about 10 minutes, day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention (PRP with VA), then Control (PRP Alone)Experimental Treatment2 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 Treatment2 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.

0 / 3Eligibility criteria met