Pivotal Study to Evaluate the Safety and Efficacy of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

NCT03573271 | Completed FDA Device

• 1 other identifier: AIS 700-00041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

Conditions

Laxity; Skin

Keywords

facial wrinkles; skin laxity; sagging skin

Outcome Measures

Primary Outcomes (1)

• Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment

  Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale

  90 day post treatment

Secondary Outcomes (1)

• Assess safety profile by recording of adverse events

  90 days

Study Arms (1)

Micro-coring of facial/neck skin with MCD

EXPERIMENTAL

Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD

Device: MCD

Interventions

MCD DEVICE

Micro-coring skin removal with automated coring device

Micro-coring of facial/neck skin with MCD

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 40-70 years of age
• Fitzpatrick Skin Type I to IV as judged by the Investigator.
• Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
• Able to provide written informed consent, understand and willing to comply with all study related procedures 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 injections in the areas to be treated
• Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
• 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
• Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
• Treatment with an investigational device or agent within 30 days before treatment or during the study period

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 Krantz

  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: June 14, 2018
• First Posted: June 29, 2018
• Study Start: March 26, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 9, 2026

Record last verified: 2021-03

Locations

US (5)