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

Cytrellis Biosystems, Inc. · NCT03793348

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
35
US sites recruiting
1
Study start
November 12, 2018
Record last updated
January 4, 2019

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: MCD

Conditions: Wrinkle

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Laser and Skin Surgery of New York

    New York, NY 10016

    Site contact: Jennifer Moreno · 212-686-7306 · research@laserskinsurgery.com

Study to Evaluate the Safety and Efficacy of the Cytrellis… (NCT03793348) | Bored Studies