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

Wrinkle Clinical Trial

— AIS  

Official title:

A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228641
• Other study ID #: 700-00001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2018
• Source: Cytrellis Biosystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 30, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Facial and Neck Skin Laxity
• Wrinkle

Intervention

Device:
• micro-excisional skin removal with coring needle

Locations

Country	Name	City	State
United States	SkinCare Physicians	Chestnut Hill	Massachusetts
United States	Dr A Jay Burns Cosmetic Surgery	Dallas	Texas
United States	Nashville Center for Laser & Facial Surgery	Nashville	Tennessee
United States	Laser & Skin Surgery Center of NY	New York	New York
United States	Laser & Skin Center of Northern CA	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Cytrellis Biosystems, Inc.

Country where clinical trial is conducted

United States, 

References & 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):216-23. doi: 10.1097/PRS.0b013e3182789afa. — View Citation

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in wrinkle appearance	One grade or better improvement in score on Wrinkle Severity Scale	60 and 90 days
Secondary	improvement in skin laxity	One grade or better improvement in score on Laxity Scale	up to 180 days