Actively Recruiting
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Led by Cytrellis Biosystems, Inc. · Updated on 2019-01-04
35
Participants Needed
6
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
CONDITIONS
Official 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 as judged by the Investigator
- Cheek wrinkles at least score 3 on the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent and willing to comply with study procedures and follow-up visits
You will not qualify if you...
- Lesions suspicious for malignancy or presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules, or active inflammatory lesions in treatment areas
- History of keloid formation or hypertrophic scarring
- Trauma or surgery to treatment areas within past 6 months
- Scar present in treatment areas
- Silicone injections in treatment areas
- Dermal fillers, fat, botulinum toxin, or other skin treatments within past 6 months in treatment areas
- Active smokers or quit smoking within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or current immunosuppressive treatment
- Sensitivity to analgesics, Aquaphor�, topical or local anesthetics, chlorhexidine, povidone-iodine, or epinephrine
- Excessive sun exposure or tanning bed/cream use within 30 days prior to treatment
- Treatment with aspirin or blood thinning agents within 14 days prior to treatment
- History or presence of significant bleeding disorders
- Any condition that interferes with safety, efficacy assessment, or participant ability
- Use of investigational device or agent within 30 days before treatment or during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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