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Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck (MCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583918
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cytrellis Biosystems, Inc.

Brief Summary:
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.

Condition or disease Intervention/treatment Phase
Laxity; Skin Device: HighThroughput Micro Coring Device Not Applicable

Detailed Description:

The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.

The subjects will be evaluated at each visit and following data will be collected:

  • The incidence and severity of systemic and local adverse events.
  • Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.
  • Changes in skin laxity assessed by Laxity Scale.
  • Canfield Image Analyses.
  • Needle and/or punch biopsy (in some subjects).
  • Overall aesthetic improvement using the following scales:
  • Subject and PI Global Aesthetic Improvement Scale (GAIS)
  • Subject Satisfaction Scale
  • Rhytides and Laxity Scale
  • Lower face assessment
  • Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Pilot Study to Evaluate the Efficacy of Micro-Excisional Skin Remodeling With Micro-Coring Device in the Treatment of Wrinkles and Skin Laxity of Face and Neck
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Highthroughput Micro Coring Device
Skin excision and removal with with Highthroughput Micro Coring device
Device: HighThroughput Micro Coring Device
Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
Other Name: skin micro-coring




Primary Outcome Measures :
  1. Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale [ Time Frame: 90-day post-treatment ]
    Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale. No wrinkles = 0; Just perceptible wrinkles = 1; Shallow wrinkles = 2; Moderately deep wrinkles = 3; Deep wrinkles, well-defined edges = 4; Very deep wrinkles, redundant fold = 5


Secondary Outcome Measures :
  1. Assess skin laxity Improvement at 90 days post treatment [ Time Frame: 90-day post-treatment ]
    Improvement in skin laxity score from the baseline assessed by Independent Reviewer using Laxity Scale and supplemented by the Canfield Image Analyses. Global Aesthetic Improvement Scale: 3 Very Much Improved; 2 Much Improved; 1 Improved; 0 No Change; - 1 Worse; - 2 Much Worse; -3 Very Much Worse.

  2. Assess skin for new collagenases [ Time Frame: 60, 90, 180-day post treatment ]
    Histological changes in treated skin when compared to untreated skin consistent with new collagenases



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 judged by the Investigator
  • Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)

    • Cheek fold lines >2
    • Upper lip lines >3
    • Nasolabial Folds >3
    • Marionette lines >3
    • Labiomental crease >3
    • Corner of the mouth lines >3
    • Periocular lines >3
  • Able to provide written informed consent, understand and willing to comply with all study related directions from investigator and follow-up visits.

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): NCT03583918


Locations
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United States, California
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
United States, Florida
Miami Dermatology and Laser Institute
Miami, Florida, United States, 33173
United States, New York
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
United States, Tennessee
The Practice of Brian S. Biesman, M.D
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: Patricia E Krantz, MBA Cytrellis Biosystems, Inc.
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Responsible Party: Cytrellis Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT03583918    
Other Study ID Numbers: Optimization of MCD treatment
AIS 700-00022 ( Other Identifier: Cytrellis Biosystems, Inc. )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cytrellis Biosystems, Inc.:
facial wrinkles
skin laxity
sagging skin
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases