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

August 6, 2024 updated by: Beauty Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Physicians will grade treatment response on days, 90, 120 and finally on day 150 using a Global Aesthetic Improvement Scale (GAIS) Standard photography will be recorded at baseline and days 30, 60, 90, 120 and finally at day 150.

Subjects will complete diaries including self-assessment of treatment response, side effects & downtime up to 7 days post treatment.

Subjects will assess treatment response on days 90, 120 and finally on day 150 using a Subject Global Aesthetic Improvement Scale (SGAIS).

Subjects will assess treatment response and satisfaction at baseline and day 150 using the Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q3) Patient reported outcome measure (PROM).

The number, type and severity of adverse events will be recorded during the duration of the study period.

At the end of the study period, photography will be assessed by three blinded physicians using the wrinkle grading scale developed by Lemperle (2001)

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Manhattan Beach, California, United States, 90266
        • Ablon Skin Institute
      • San Diego, California, United States, 92121
        • West Dermatology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male & females; 35 to 75 years of age with signs of facial aging.
  • Fitzpatrick I-VI phototype skin types.
  • Volunteers with wrinkle grading of 1 to 4 according to Lemperle (2001) wrinkle grading scale.
  • Volunteers with a laxity grading of 1-3.5 according to Alexiandes Armenakas (2010) grading scale.
  • Written informed consent is given.
  • Females of childbearing potential (FOCBP) and females who are premenses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing, injection, transdermal patch or abstinence.)
  • Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study.
  • Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study.
  • Volunteers agree NOT to use any topical agents containing active ingredients such as retinol, glycolic acid in the treatment area, during the study period.
  • Volunteers agree NOT to undergo any aesthetic treatments (such as Botox, fillers, microdermabrasion, laser surfacing etc.) in the treatment area, during the study period.

Exclusion Criteria:

  • Volunteers have used a topical anti-aging product containing active ingredients within 4 weeks of commencing the study.
  • Volunteers suffer from Hemophilia or other clotting/bleeding disorders.
  • Volunteers taking anticoagulant therapy, e.g., warfarin, heparin.
  • Volunteers who have used aspirin continuously in the last 2 weeks.
  • Volunteers with active acne vulgaris of the face.
  • Volunteers who have stopped taking birth control pills within the last 3 months.
  • Volunteers suffer from uncontrolled diabetes mellitus.
  • Volunteers with known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
  • Volunteers suffer from keloid scars, Human Papilloma virus (HPV) or birth marks in the treatment area.
  • Volunteers have a tendency for keloid scar formation.
  • Volunteers suffer from eczema or skin rashes in the treatment area.
  • Volunteers suffer from systemic infections such as hepatitis.
  • Volunteers have known allergy to topical/local anesthetics.
  • Volunteers have continuously used high dose NSAIDs for the last 2 weeks.
  • Volunteers have undergone plastic surgery in the treatment area within the last 6 months.
  • Volunteers have undergone filler injections in the treatment area within the last 6 months.
  • Volunteers have received Botox or other neuromodulators injections in the treatment area within the last 6 months.
  • Females who are pregnant, breast-feeding or who wish to become pregnant during the study period.
  • Enrolled in another clinical trial during the same study period.
  • Volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial, and which may interfere with the course or outcome of the study.
  • Volunteering has medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
  • Volunteer is undergoing or is likely to undergo other treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microneedling
4 microneedling sessions at baseline and days 30, 60 and 90.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrinkle improvement
Time Frame: 120 and 150 days after the first treatment

Mean improvement over baseline of one grade for wrinkles utilizing the Lemperle (2001) grading scale scores of the periorbital, cheek folds and glabellar lines 120 and 150 days after the first treatment.

The Lemperle Wrinkle Grading Scale, is used to assess the severity of facial wrinkles.

The scale divides the face into distinct facial areas (horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek folds, nasolabial folds, upper lip lines, corner of mouth line, marionette lines and chin crease). Each area is classified 0-5, (0-No wrinkles, 5-Very deep wrinkles).

Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001;108(6):1735-1750.
120 and 150 days after the first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Texture and laxity
Time Frame: 120 and 150 days after the first treatment
Mean improvement over baseline of one grade for skin laxity and texture 120 and 150 days after the first treatment using a scale developed by Alexiandes Armenakas This is a modified texture and laxity grading scale adapted from the complete grading scale developed by Alexiandes Armenakas (2010). The scale is an 8 point descriptive scale (0-4, with 0.4 increments). Where 0 is no visible evidence of skin laxity or texture and 4 is severe skin laxity and skin roughness (texture)
120 and 150 days after the first treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 150 days
Incidence and degree of (adverse events) side effects
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beauty Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

May 9, 2024

Study Completion (Actual)

May 9, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASIRC_SSMS_07-14-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan for data to be published in peer reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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