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

NCT03583918 | Completed FDA Device

• 2 other identifiers: Optimization of MCD treatmentAIS 700-00022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Laxity; Skin

Keywords

facial wrinkles; skin laxity; sagging skin

Outcome Measures

Primary Outcomes (1)

• 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

  90-day post-treatment

Secondary Outcomes (2)

• Assess skin laxity Improvement at 90 days post treatment

  90-day post-treatment

• Assess skin for new collagenases

  60, 90, 180-day post treatment

Study Arms (1)

Highthroughput Micro Coring Device

EXPERIMENTAL

Skin excision and removal with with Highthroughput Micro Coring device

Device: HighThroughput Micro Coring Device

Interventions

HighThroughput Micro Coring Device DEVICE

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

Also known as: skin micro-coring

Highthroughput Micro Coring Device

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (5)

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

The Practice of Brian S. Biesman, M.D

Nashville, Tennessee, 37203, United States

Location

Dr A Jay Burns Cosmetic Surgery

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Patricia E Krantz, MBA

  Cytrellis Biosystems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: July 12, 2018
• Study Start: June 1, 2017
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

US (5)