Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
- Conditions
- Laxity; Skin
- Interventions
- Device: MCD
- Registration Number
- NCT03573271
- Lead Sponsor
- Cytrellis Biosystems, Inc.
- Brief Summary
Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Micro-coring of facial/neck skin with MCD MCD Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD
- Primary Outcome Measures
Name Time Method Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment 90 day post treatment Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
- Secondary Outcome Measures
Name Time Method Assess safety profile by recording of adverse events 90 days Adverse events will be recorded throughout the study
Trial Locations
- Locations (5)
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
Dr A Jay Burns Cosmetic Surgery
🇺🇸Dallas, Texas, United States
The Practice of Brian S. Biesman, M.D
🇺🇸Nashville, Tennessee, United States