NCT04136847

Study to Evaluate the Efficacy and Tolerability of the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging

A Single-Center Trial to Evaluate the Efficacy and Tolerability of the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bellus Medical, LLC · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Bellus Medical is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand.

Detailed description

SkinPen microneedling treatment of dorsal hand skin This is a single-site, non-randomized, non-controlled study designed to follow at least twenty three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments. The sample size determination of this study is based on the recommendations of the sponsor. These patients will be treated four times over the dorsum of the hand from the wrist to the knuckles each month for four months, followed by two follow-up visits at 1-month and 3-months post-treatment. The acute effects of microneedling will be determined by subjective and objective analysis using standard and close-up photography. Additionally, the effects of this treatment will be analyzed at 1-month and 3-month post-treatment through clinician and subject assessments. Subjects will be identified from Dr. Jeffrey Kenkel's clinical practice at the University of Texas Southwestern Medical Center. Subjects will be numbered sequentially in the order in which they qualify for entry into the study.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	SkinPen Precision	Surgical instrument motors and accessories/attachments/Hydrogel

Timeline

• Start date: 2020-01-10
• Primary completion: 2020-05-26
• Completion: 2020-05-26
• First posted: 2019-10-23
• Last updated: 2021-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study