Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Purpose
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Condition
- Wrinkle
Eligibility
- Eligible Ages
- Between 40 Years and 70 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Micro-exisional skin removal |
Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment. |
|
Recruiting Locations
Laser and Skin Surgery of New York
New York, New York 10016
New York, New York 10016
More Details
- Status
- Recruiting
- Sponsor
- Cytrellis Biosystems, Inc.
Study Contact
Detailed 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