Actively Recruiting
A Study to Evaluate Safety and Efficacy of the Cytrellis Micro-Coring Device for Moderate to Severe Facial Wrinkles
Led by Cytrellis Biosystems, Inc. · Updated on 2019-01-04
35
Participants Needed
6
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Cytrellis Micro-Coring Device for treating moderate to severe wrinkles on the face, specifically focusing on the cheeks and neck areas. This study involves up to 35 adults aged 40 to 70 years with Fitzpatrick Skin Types I to IV. The goal is to improve skin appearance by reducing wrinkle severity using this novel device. Participants will undergo one treatment session using the micro-coring device, which removes small sections of skin on the face and neck. Following this treatment, participants will be monitored closely for 90 days to assess changes and any side effects. The study includes various methods to evaluate wrinkle improvement, such as the Lemperle Wrinkle Severity Scale and other aesthetic improvement scales. During the study, participants will have scheduled assessments to measure wrinkle severity and satisfaction with treatment results. Safety monitoring will include recording any adverse events immediately after treatment and at several follow-up visits up to 90 days later. Participants will also complete a diary for two weeks post-treatment to track any side effects. The total involvement period for each participant is approximately three months.
CONDITIONS
Brief Title
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 40 to 70 years
- Fitzpatrick Skin Type I to IV
- Cheek wrinkles scored at least 3 on the Lemperle Wrinkle Assessment Scale
- Able to provide written informed consent and comply with study procedures and visits
You will not qualify if you...
- Suspicious lesions or active inflammatory skin conditions in treatment areas
- History of keloid formation or hypertrophic scarring
- Trauma or surgery to treatment areas within past 6 months
- Scars or silicone injections in treatment areas
- Recent injections of dermal fillers, fat, botulinum toxin, or skin treatments within 6 months
- Active smokers or recent quitters within 3 months
- Active, chronic, or recurrent infections
- Compromised immune system or immunosuppressive treatment
- Sensitivity to analgesics, topical anesthetics, or antiseptics used in the study
- Excessive sun exposure or tanning within 30 days prior to treatment
- Use of blood thinning agents within 14 days prior to treatment
- Clinically significant bleeding disorders
- Any condition interfering with safety or efficacy assessment
- Use of investigational device or agent within 30 days before or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo micro-coring skin removal treatment on the facial and neck areas using the Cytrellis Micro-Coring Device.
1 treatment visit (in-person)
Duration - 90 days
Participants are monitored for safety and efficacy for 90 days after treatment, including recording of adverse events and completion of a 14-day diary for potential side effects.
Visits on Day 1, Day 7, Day 30, Day 60, and Day 90 post treatment; additional assessments as needed
Trial Site Locations
Total: 6 locations
1
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
Active, Not Recruiting
2
AboutSkin Research, LLC
Greenwood Village, Colorado, United States, 80111
Not Yet Recruiting
3
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
Active, Not Recruiting
4
Laser and Skin Surgery of New York
New York, New York, United States, 10016
Actively Recruiting
5
The Office of Brian Biesman, M.D.
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
6
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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