NCT04912219

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

May 28, 2021

Last Update Submit

May 28, 2021

Conditions

Solar Purpura

Outcome Measures

Primary Outcomes (2)

  • Skin thickness

    Thickness of skin as measured by skin biopsy

    one year

  • Skin thickness ultrasound

    Thickness of skin as measured by ultrasound

    6 months

Secondary Outcomes (2)

  • Dermatology-related quality of life

    six months and one year

  • Number of ecchymoses

    six months and one year

Study Arms (2)

Treatment

EXPERIMENTAL
Device: Microneedling

Control

NO INTERVENTION

Interventions

MicroneedlingDEVICE

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

Treatment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Richard M McLarney, MD

    Resident

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard M McLarney, MD

CONTACT

956-802-0558matt.mclarney@gmail.com

Naomi Lawrence, MD

CONTACT

856-596-3040lawrence-naomi@cooperhealth.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 3, 2021

Study Start

August 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share