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

NCT ID: NCT03583918

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-06-13

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.

Conditions

Laxity; Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Highthroughput Micro Coring Device

Skin excision and removal with with Highthroughput Micro Coring device

Group Type: EXPERIMENTAL

HighThroughput Micro Coring Device

Intervention Type: DEVICE

Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device

Interventions

HighThroughput Micro Coring Device

Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device

Intervention Type: DEVICE

Other Intervention Names

skin micro-coring

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cytrellis Biosystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia E Krantz, MBA

Role: STUDY_DIRECTOR

Cytrellis Biosystems, Inc.

Locations

Laser and Skin Surgery Center of Northern California

Sacramento, California, United States

Miami Dermatology and Laser Institute

Miami, Florida, United States

Laser and Skin Surgery Center of New York

New York, New York, United States

The Practice of Brian S. Biesman, M.D

Nashville, Tennessee, United States

Dr A Jay Burns Cosmetic Surgery

Dallas, Texas, United States

Countries

United States

Other Identifiers

AIS 700-00022

Identifier Type: OTHER

Identifier Source: secondary_id

Optimization of MCD treatment

Identifier Type: -

Identifier Source: org_study_id