Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-06-16 @ 8:33 PM
Study NCT ID:
NCT03803059
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
Sponsor:
Bellus Medical, LLC
Organization:
Study Overview
Official Title:
A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: