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Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles

NCT06032286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-08-07

No results posted yet for this study

Summary

To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in reducing the appearance of facial wrinkles.This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90.

Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a modified Alexiandes Armenakas (2010) grading scale.

Conditions

  • Subjects Displaying Facial Ageing

Interventions

DEVICE

Skinstylus microneedling device

Microneedling, also known as percutaneous collagen induction (PCI), is a minimally invasive technique where small needles create microscopic wounds in the skin inducing collagen formation.

Sponsors & Collaborators

  • Beauty Health

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-05-09
Completion
2024-05-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032286 on ClinicalTrials.gov