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

NCT ID: NCT03228641

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-04-30

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).

Detailed Description

This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density.

There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.

Conditions

Wrinkle; Facial and Neck Skin Laxity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

micro-excisional skin removal

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

Group Type: EXPERIMENTAL

micro-excisional skin removal with coring needle

Intervention Type: DEVICE

Interventions

micro-excisional skin removal with coring needle

Intervention Type: DEVICE

Other Intervention Names

micro-coring, micro-excisional skin removal

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cytrellis Biosystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michail M Pankratov, MD, PhD

Role: STUDY_DIRECTOR

Senior Vice President of Clinical & Regulatory Affairs

Patricia E Krantz

Role: STUDY_DIRECTOR

Director of Clinical Operations

Locations

Laser & Skin Center of Northern CA

Sacramento, California, 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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23357983 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26627306 (View on PubMed)

Other Identifiers

700-00001

Identifier Type: -

Identifier Source: org_study_id