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

A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

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

Study Overview

• Status: Unknown
• Conditions: Laxity; Skin
• Intervention / Treatment: Device: MCD

Detailed Description

Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.

Evaluation results will be based in the following:

• Wrinkle severity score assessed using the Lemperle Wrinkle Scale
• Subject Satisfaction Scale
• PI Global Aesthetic Improvement Scale

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Active, not recruiting
      • Laser and Skin Surgery Center of Northern California
  • Florida
    • Miami, Florida, United States, 33173
      • Recruiting
      • Miami Dermatology and Laser Institute
      • Contact: Nicole Rieth; Phone Number: 305-279-6060; Email: nicoler@miamidermlaser.com
  • New York
    • New York, New York, United States, 10016
      • Not yet recruiting
      • Laser and Skin Surgery Center of New York
      • Contact: Brittany Schmidt; Phone Number: 212-686-7306
      • Principal Investigator: Roy Geroneumus, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • The Practice of Brian S. Biesman, M.D
  • Texas
    • Dallas, Texas, United States, 75231
      • Not yet recruiting
      • Dr A Jay Burns Cosmetic Surgery
      • Contact: Casey Martin; Phone Number: 603-332-5211
      • Principal Investigator: A. Jay Burns, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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 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
• Female and pregnant or plan on becoming pregnant during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micro-coring of facial/neck skin with MCD; 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; Micro-coring skin removal with automated coring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess safety profile by recording of adverse events	Adverse events will be recorded throughout the study	90 days

Collaborators and Investigators

• Sponsor: Cytrellis Biosystems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Anticipated): January 15, 2019
• Study Completion (Anticipated): March 21, 2019

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: facial wrinkles; skin laxity; sagging skin
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: AIS 700-00041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No