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

NCT03228641 | Completed FDA Device

• 1 other identifier: 700-00001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Wrinkle; Facial and Neck Skin Laxity

Keywords

skin rejuvenation; wrinkle removal; skin laxity reduction

Outcome Measures

Primary Outcomes (1)

• improvement in wrinkle appearance

  One grade or better improvement in score on Wrinkle Severity Scale

  60 and 90 days

Secondary Outcomes (1)

• improvement in skin laxity

  up to 180 days

Study Arms (1)

micro-excisional skin removal

EXPERIMENTAL

Facial and neck wrinkles will be treated with micro-excisional skin removal

Device: micro-excisional skin removal with coring needle

Interventions

micro-excisional skin removal with coring needle DEVICE

Also known as: micro-coring, micro-excisional skin removal

micro-excisional skin removal

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (6)

Laser & Skin Center of Northern CA

Sacramento, California, 95816, United States

Location

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Laser & Skin Surgery Center of NY

New York, New York, 10016, United States

Location

Nashville Center for Laser & Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Dr A Jay Burns Cosmetic Surgery

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• Fernandes JR, Samayoa JC, Broelsch GF, McCormack MC, Nicholls AM, Randolph MA, Mihm MC, Austen WG Jr. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg. 2013 Feb;131(2):216-223. doi: 10.1097/PRS.0b013e3182789afa.

  PMID: 23357983 RESULT

• Russe E, Purschke M, Farinelli WA, Wang Y, Doukas AG, Limpiangkanan W, Sakamoto FH, Tam J, Wechselberger G, Anderson RR. Micro-fractional, directional skin tightening: A porcine model. Lasers Surg Med. 2016 Mar;48(3):264-9. doi: 10.1002/lsm.22444. Epub 2015 Dec 2.

  PMID: 26627306 RESULT

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michail M Pankratov, MD, PhD

  Senior Vice President of Clinical & Regulatory Affairs

  STUDY DIRECTOR

• Patricia E Krantz

  Director of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: subject is blinded to the needle gauge and density of treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: July 25, 2017
• Study Start: June 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: March 25, 2026

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)