Recruiting

Cytrellis

Sponsor:

Cytrellis Biosystems, Inc.

Code:

NCT03793348

Conditions

Wrinkle

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

MCD

Study Details

Brief summary:

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

Conditions

Wrinkle

Study ID

NCT03793348

Start date

Nov 12, 2018

Status verified date

Jan, 2019

Completion date

Aug 21, 2019

Anticipated

Primary completion date

Jun 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Micro-exisional skin removal

Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment.

Interventions

MCD

Micro coring skin removal with automated coring device

Primary outcome measure

  • Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale [ Time Frame: 90 day post treatment ]

Central Contacts and Locations

Locations

Laser and Skin Surgery of New York

Recruiting

New York, New York, United States, 10016

Contacts

Jennifer Moreno

212-686-7306research@laserskinsurgery.com

Principal Investigator:

Roy Geronemus

More Information

Sponsor

Cytrellis Biosystems, Inc.

Last update posted

Jan 4, 2019

Last verified

Jan, 2019

Keywords

  • facial wrinkles
  • skin laxity
  • sagging skin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cytrellis Biosystems, Inc. on 2019-01-04.