A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Cytrellis Biosystems, Inc.
Summary
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Description
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment. Study results will be assessed with the following: * Lemperle Scale * Investigator GAIS Scale * Subject Satisfaction Scale
Eligibility
- Age range
- 40–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 formatio…
Interventions
- DeviceMCD
Micro coring skin removal with automated coring device
Locations (6)
- Laser and Skin Surgery Center of Northern CaliforniaSacramento, California
- AboutSkin Research, LLCGreenwood Village, Colorado
- Miami Dermatology & Laser InstituteMiami, Florida
- Laser and Skin Surgery of New YorkNew York, New York
- The Office of Brian Biesman, M.D.Nashville, Tennessee
- Dallas Plastic Surgery InstituteDallas, Texas