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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)

Primary Purpose

Laxity; Skin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HighThroughput Micro Coring Device
Sponsored by
Cytrellis Biosystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laxity; Skin focused on measuring facial wrinkles, skin laxity, sagging skin

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laser and Skin Surgery Center of Northern California
  • Miami Dermatology and Laser Institute
  • Laser and Skin Surgery Center of New York
  • The Practice of Brian S. Biesman, M.D
  • Dr A Jay Burns Cosmetic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Highthroughput Micro Coring Device

Arm Description

Skin excision and removal with with Highthroughput Micro Coring device

Outcomes

Primary Outcome Measures

Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale
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

Assess skin laxity Improvement at 90 days 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.
Assess skin for new collagenases
Histological changes in treated skin when compared to untreated skin consistent with new collagenases

Full Information

First Posted
August 16, 2017
Last Updated
July 10, 2018
Sponsor
Cytrellis Biosystems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03583918
Brief Title
Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck
Acronym
MCD
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytrellis Biosystems, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laxity; Skin
Keywords
facial wrinkles, skin laxity, sagging skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Highthroughput Micro Coring Device
Arm Type
Experimental
Arm Description
Skin excision and removal with with Highthroughput Micro Coring device
Intervention Type
Device
Intervention Name(s)
HighThroughput Micro Coring Device
Other Intervention Name(s)
skin micro-coring
Intervention Description
Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
Primary Outcome Measure Information:
Title
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale
Description
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
Time Frame
90-day post-treatment
Secondary Outcome Measure Information:
Title
Assess skin laxity Improvement at 90 days post treatment
Description
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.
Time Frame
90-day post-treatment
Title
Assess skin for new collagenases
Description
Histological changes in treated skin when compared to untreated skin consistent with new collagenases
Time Frame
60, 90, 180-day post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia E Krantz, MBA
Organizational Affiliation
Cytrellis Biosystems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Laser and Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Miami Dermatology and Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Laser and Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Practice of Brian S. Biesman, M.D
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dr A Jay Burns Cosmetic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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