Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

Cytrellis

Status

Unknown

Conditions

Laxity; Skin

Treatments

Device: MCD

Study type

Interventional

Funder types

Industry

Identifiers

NCT03573271

AIS 700-00041

Details and patient eligibility

About

Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

Full description

Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.

Evaluation results will be based in the following:

Wrinkle severity score assessed using the Lemperle Wrinkle Scale
Subject Satisfaction Scale
PI Global Aesthetic Improvement Scale

Enrollment

20 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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
Female and pregnant or plan on becoming pregnant during the study