NCT05030051

A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Crown Laboratories, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.

Detailed description

A total of 18 subjects will be enrolled in this study. These patients will be treated three times over the dorsum of the hand from the wrist to the knuckles each month for three months, followed by one follow-up visit at 3-months post-treatment. Blueberry and Crown Laboratories will be responsible for recruitment efforts. Subjects will be numbered sequentially in the order in which they qualify for entry into the study. 3.2 Primary Endpoints • Clinician's global aesthetic improvement assessment (CGAIS) at 3-months post-treatment. 3.3 Secondary Endpoints * Subject's global aesthetic improvement assessment (SGAIS) at 3-months post-treatment. * Monitoring of adverse events throughout the course of the study. Safety Subject diaries will be monitored for resolution of anticipated treatment responses. 3.4 Exploratory Endpoints • Bioinstrumentation: TEWL, hydration, elasticity, skin thickness measurements at each visit.

Conditions

• Skin Aging

Interventions

Type	Name	Description
DEVICE	SkinPen Precision System	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 Crown Laboratories 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. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit.

Timeline

• Start date: 2021-03-12
• Primary completion: 2022-06-30
• Completion: 2022-11-30
• First posted: 2021-09-01
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study