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

Cytrellis

Status

Completed

Conditions

Laxity; Skin

Treatments

Device: HighThroughput Micro Coring Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03583918

Optimization of MCD treatment

AIS 700-00022 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.

The subjects will be evaluated at each visit and following data will be collected:

The incidence and severity of systemic and local adverse events.
Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.
Changes in skin laxity assessed by Laxity Scale.
Canfield Image Analyses.
Needle and/or punch biopsy (in some subjects).
Overall aesthetic improvement using the following scales:
Subject and PI Global Aesthetic Improvement Scale (GAIS)
Subject Satisfaction Scale
Rhytides and Laxity Scale
Lower face assessment
Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.

Enrollment

50 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

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 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