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Study of Cytrellis Micro-Coring Device for Facial Wrinkles

This study is testing a device called MCD (Micro coring skin removal with automated coring device) to see how safe and effective it is for treating moderate to severe facial wrinkles. Researchers are looking for up to 35 people, aged 40 to 70, with Fitzpatrick Skin Type I to IV (a way to classify skin based on how it reacts to sun exposure) and moderate to severe cheek wrinkles. The main goal is to see how much wrinkles improve after 90 days using a scale called the Lemperle Wrinkle Severity Scale. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll up to 35 participants. It is designed to evaluate the safety and effectiveness of the MCD device.
What's involved
You would receive treatment with the MCD device and be monitored for 90 days after the treatment. Your wrinkles will be assessed using several scales.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 90 days after treatment.

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NCT03793348

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

Recruiting
NAAges 40–70InterventionalTreatment
Cytrellis Biosystems, Inc.
~35 participants
Updated 2019-01-04 on ClinicalTrials.gov
What's tested:MCD

At a glance

Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
Measured over 90 day post treatment

Conditions

Wrinkle

Explore related trials

Cutis LaxaWrinkled face

Where it's being run

6 sites across 6 states
California1
Colorado1
Florida1
New York1
Tennessee1
Texas1

Who to contact

Jennifer Moreno
[email protected]
212-686-7306
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale90 day post treatment

    A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle 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