Menu
Recruiting NCT03793348

Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

No phase Interventional Wrinkle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MCD.
Who it may be relevant to
Registry conditions: Wrinkle. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

Detailed description

Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.

Study results will be assessed with the following:

* Lemperle Scale * Investigator GAIS Scale * Subject Satisfaction Scale

Interventions

  • Device MCD
    Micro coring skin removal with automated coring device

Primary outcome measures

  • Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale [Time frame: 90 day post treatment]
Secondary outcome measures (6)
  • Assess aesthetic improvement using Global Aesthetic Improvement Scale [Time frame: 90 day post treatment]
  • Assess aesthetic improvement using Subject Satisfaction Scale [Time frame: 90 day post treatment]
  • Assess aesthetic improvement in wrinkles using OCT images (optional) [Time frame: Baseline to Day 90 post treatment]
  • Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment. [Time frame: Baseline to Day 90 post treatment]
  • Assess safety profile by recording of adverse events [Time frame: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.]
  • Assess safety profile by reviewing completed 14 day subject diary for potential side effects. [Time frame: For 14 days post treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Laser and Skin Surgery Center of Northern California — Sacramento
  • AboutSkin Research, LLC — Greenwood Village
  • Miami Dermatology & Laser Institute — Miami
  • Laser and Skin Surgery of New York — New York
  • The Office of Brian Biesman, M.D. — Nashville
  • Dallas Plastic Surgery Institute — Dallas

Identifiers

NCT: NCT03793348 · AIS 700-00052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗