Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity

Completed · Not applicable

Conditions studied: Wrinkle, Facial and Neck Skin Laxity

In brief

A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).

Key facts

Study ID

NCT03228641

Run by

Cytrellis Biosystems, Inc.

People needed

45

Starts

2016-06-01

Expected to finish

2017-08-31

Last updated by the study team

2026-03-25

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
• One or more of the following conditions assessed by Investigator using provided Severity Scales:
• Nasolabial fold severity at rest ≥2 and ≤4;
• Marionette line prominence at rest ≥2 and ≤4;
• Oral commissure drooping at rest ≥2 and ≤4;
• Jawline sagging at rest ≥2 and ≤4 .
• Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.

You may not qualify if…

• Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
• History of keloid formation or hypertrophic scarring
• History of trauma or surgery to the treatment areas in the past 6 months
• Scar present in the areas to be treated
• Silicone or synthetic material injections in the areas to be treated
• Injection of FDA-approved dermal fillers in the past two years
• Injection of fat in the past year
• History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
• History of treatment with non-ablative laser in the past 6 months
• History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
• Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
• Active, chronic, or recurrent infection
• History of compromised immune system or currently being treated with immunosuppressive agents
• History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
• Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
• Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
• History or presence of any clinically significant bleeding disorder
• Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
• History of drug and/or alcohol abuse
• Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
• Treatment with an investigational device or agent within 30 days before treatment or during the study period

Where it is running

• Laser & Skin Center of Northern CA — Sacramento, California, United States
• Miami Dermatology and Laser Institute — Miami, Florida, United States
• SkinCare Physicians — Chestnut Hill, Massachusetts, United States
• Laser & Skin Surgery Center of NY — New York, New York, United States
• Nashville Center for Laser & Facial Surgery — Nashville, Tennessee, United States
• Dr A Jay Burns Cosmetic Surgery — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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