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

NCT06032286 | Completed FDA Device

• 1 other identifier: ASIRC_SSMS_07-14-23
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Wrinkles; Facial ageing; Micro needling

Outcome Measures

Primary Outcomes (1)

• Wrinkle improvement

  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 Outcomes (1)

• Texture and laxity

  120 and 150 days after the first treatment

Other Outcomes (1)

• Adverse events

  150 days

Study Arms (1)

Microneedling

EXPERIMENTAL

4 microneedling sessions at baseline and days 30, 60 and 90.

Device: Skinstylus microneedling device

Interventions

Skinstylus microneedling device 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.

Microneedling

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beauty Health: lead

Study Sites (2)

Ablon Skin Institute

Manhattan Beach, California, 90266, United States

Location

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Related Publications (6)

• Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.

  PMID: 11711957 BACKGROUND

• Alexiades-Armenakas M. A quantitative and comprehensive grading scale for rhytides, laxity, and photoaging. J Drugs Dermatol. 2006 Sep;5(8):808-9. No abstract available.

  PMID: 16989197 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013 Apr;40(2):249-60. doi: 10.1016/j.cps.2012.12.001.

  PMID: 23506765 BACKGROUND

• Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995 Jun;21(6):543-9. doi: 10.1111/j.1524-4725.1995.tb00259.x.

  PMID: 7773602 BACKGROUND

• Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.

  PMID: 28796657 BACKGROUND

• Ablon G. Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.

  PMID: 30214664 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group, all subjects will receive intervention.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: September 8, 2023
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)