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Microneedling for Dermatoporosis

NCT04912219 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-06-03

No results posted yet for this study

Summary

We hypothesize that a series of treatments with a microneedling protocol will lead to increased dermal thickness as measured by biopsy, ultrasound, and skin calipometry; an improvement in dermatology-related quality of life; and a reduction in the number of ecchymoses and skin tears, of the research subjects.

Conditions

  • Solar Purpura

Interventions

DEVICE

Microneedling

Skin will be pretreated with topical 15% lidocaine creaml for 20 minutes. Water-soaked gauze will then be used to remove the lidocaine gel. Treated skin will be cleaned with 70% ethyl alcohol, allowed to dry, and then treated with hyaluronic acid gel. Manual traction will be applied to the skin of the treatment arm, and the SkinPen microneedle device with 0.5mm microneedles attached will be passed over the forearm skin in a cross-hatch pattern until an endpoint of fine pinpoint bleeding is achieved. Manual pressure with sterile ice water compresses will be used until hemostasis is achieved. This will be repeated for a total of four treatments one month apart

Sponsors & Collaborators

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Richard M McLarney, MD · Resident

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912219 on ClinicalTrials.gov