Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck

Completed · Not applicable

Conditions studied: Laxity; Skin

In brief

This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.

Key facts

Study ID: NCT03583918
Run by: Cytrellis Biosystems, Inc.
People needed: 50
Starts: 2017-06-01
Expected to finish: 2018-06-13
Last updated by the study team: 2018-07-12

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Fitzpatrick Skin Type 1, 2, or 3 as judged by the Investigator
Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)
Cheek fold lines >2
Upper lip lines >3
Nasolabial Folds >3
Marionette lines >3
Labiomental crease >3
Corner of the mouth lines >3
Periocular lines >3
Able to provide written informed consent, understand and willing to comply with all study related directions from investigator and follow-up visits.

You may not qualify if…

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 or synthetic material injections in the areas to be treated
Injection of FDA-approved dermal fillers in the past two years
Injection of fat in the past year
History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
History of treatment with non-ablative laser in the past 6 months
History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
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
Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
History of drug and/or alcohol abuse
Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
Treatment with an investigational device or agent within 30 days before treatment or during the study period

Where it is running

Laser and Skin Surgery Center of Northern California — Sacramento, California, United States
Miami Dermatology and Laser Institute — Miami, Florida, United States
Laser and Skin Surgery Center of New York — New York, New York, United States
The Practice of Brian S. Biesman, M.D — Nashville, Tennessee, United States
Dr A Jay Burns Cosmetic Surgery — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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