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

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ClinicalTrials.gov Identifier: NCT03228641
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Cytrellis Biosystems, Inc.

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).

Condition or disease Intervention/treatment Phase
Wrinkle Facial and Neck Skin Laxity Device: micro-excisional skin removal with coring needle Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: subject is blinded to the needle gauge and density of treatment
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: micro-excisional skin removal
Facial and neck wrinkles will be treated with micro-excisional skin removal
Device: micro-excisional skin removal with coring needle
Other Name: micro-coring, micro-excisional skin removal




Primary Outcome Measures :
  1. improvement in wrinkle appearance [ Time Frame: 60 and 90 days ]
    One grade or better improvement in score on Wrinkle Severity Scale


Secondary Outcome Measures :
  1. improvement in skin laxity [ Time Frame: up to 180 days ]
    One grade or better improvement in score on Laxity Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228641


Locations
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United States, California
Laser & Skin Center of Northern CA
Sacramento, California, United States, 95816
United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
United States, Tennessee
Nashville Center for Laser & Facial Surgery
Nashville, Tennessee, United States, 37203
United States, Texas
Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Cytrellis Biosystems, Inc.
Investigators
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Study Director: Michail M Pankratov, MD, PhD Senior Vice President of Clinical & Regulatory Affairs
Study Director: Patricia E Krantz Director of Clinical Operations

Publications of Results:
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Responsible Party: Cytrellis Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT03228641     History of Changes
Other Study ID Numbers: 700-00001
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Clinical data analysis will be summarized in the Clinical Study Report and later submitted for publication in the peer-reviewed journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cytrellis Biosystems, Inc.:
skin rejuvenation
wrinkle removal
skin laxity reduction

Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases