NCT03803059

Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck

A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Bellus Medical, LLC · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This single-center, the clinical trial is being conducted over the course of 90 days followed by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck.

Detailed description

A total of 32 subjects completed study participation. At visit 1 (baseline), subjects were screened for eligibility criteria, and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2. On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's wrinkles of the neck with SkinPen Precision System at depths of up to 2.5mm. During the post-treatment period, Clinical evaluations were conducted at visit 2 (day 1), visit 3 (day 30), visit 4 (day 60), visit 5 (day 90), visit 6 (1month post-treatment), and visit 7 (3 months post-treatment)

Conditions

• Wrinkles

Interventions

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

Timeline

• Start date: 2019-01-31
• Primary completion: 2020-01-10
• Completion: 2020-01-10
• First posted: 2019-01-14
• Last updated: 2021-12-01
• Results posted: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study