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

Last updated: January 2, 2019
Sponsor: Cytrellis Biosystems, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03793348
AIS 700-00052
  • Ages 40-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 asjudged by the Investigator

  • Able to provide written informed consent, understand and willing to comply with allstudy related procedures and follow-up visits.

Exclusion

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 betreated

  • 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 minimallyinvasive/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 immunosuppressiveagents

  • History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine orepinephrine

  • Excessive sun exposure and use of tanning beds or tanning creams within 30 days priorto treatment

  • Treatment with aspirin or other blood thinning agents within 14 days prior totreatment

  • History or presence of any clinically significant bleeding disorder

  • Any issue that, at the discretion of the Investigator, would interfere with assessmentof 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 orduring the study period

Study Design

Total Participants: 35
Study Start date:
November 12, 2018
Estimated Completion Date:
August 21, 2019

Study 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

Connect with a study center

  • Laser and Skin Surgery Center of Northern California

    Sacramento, California 95816
    United States

    Site Not Available

  • AboutSkin Research, LLC

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Miami Dermatology & Laser Institute

    Miami, Florida 33173
    United States

    Site Not Available

  • Laser and Skin Surgery of New York

    New York, New York 10016
    United States

    Active - Recruiting

  • The Office of Brian Biesman, M.D.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Dallas Plastic Surgery Institute

    Dallas, Texas 75231
    United States

    Site Not Available

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