Clinical trial NCT03228641: Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Facial and Neck Skin Laxity
Keywords: skin rejuvenation
wrinkle removal
skin laxity reduction
Lead sponsor: Cytrellis Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-25
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: improvement in wrinkle appearance
timeFrame: 60 and 90 days
Secondary outcomes:
measure: improvement in skin laxity
timeFrame: up to 180 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Center of Northern CA
state: California
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: New York
country: United States
facility: Laser & Skin Surgery Center of NY
state: New York
city: Nashville
country: United States
facility: Nashville Center for Laser & Facial Surgery
state: Tennessee
city: Dallas
country: United States
facility: Dr A Jay Burns Cosmetic Surgery
state: Texas
Study officials:
affiliation: Senior Vice President of Clinical & Regulatory Affairs
name: Michail M Pankratov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Director of Clinical Operations
name: Patricia E Krantz
role: STUDY_DIRECTOR
References:
citation: 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.
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 2015 Dec 2.