Considerations for the Use of Fitzpatrick Skin Type in Plastic Surgery Research.
Sangeeta K Subedi, Oren Ganor
https://pubmed.ncbi.nlm.nih.gov/38841534Actively Recruiting
Age: 30Years - 65Years
All Genders
ID07224880
Safety and Outcomes of Ellacor4 Micro-Coring Technology4 in Fitzpatrick Skin Types I-VI Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs): A Case Series
Led by Cytrellis Biosystems, Inc. · Updated on 2025-12-31
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Ellacor4 Micro-Coring Technology4 device in people with Fitzpatrick Skin Types I through VI, including those taking GLP-1 receptor agonists, a type of medication that helps control blood sugar and supports weight loss. The study aims to understand how the device works on different skin types and treatment areas, and to observe any changes in treated skin compared to untreated skin. Side effects related to this treatment will also be monitored. Wrinkle severity reduction will be measured using standardized 2D imaging techniques. The device uses hollow coring needles to remove tiny, full-thickness skin cores about 0.4 millimeters wide, which is larger than standard microneedling that only punctures without removing tissue. The skin removal is small enough to avoid visible scarring. After treatment, the skin repairs itself by producing new collagen and elastin fibers. Participants will receive the same number of Ellacor4 treatments during the study, which lasts up to 90 days. Study visits include an initial screening and enrollment visit, one treatment visit, and four follow-up visits on Days 3, 7, 30, and 90, with an optional additional follow-up if needed. Participants will attend at least six visits lasting 30 to 90 minutes each. Assessments include imaging to quantify wrinkle reduction and monitoring for safety and side effects. Participation ends after the Day 90 follow-up. The study will include 10 to 30 people, all treated at one center. Participants may have their screening and treatment visits on the same day, with total study involvement lasting about three months.
CONDITIONS
Brief Title
Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists
Who Can Participate
Age: 30Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female adults between the ages of 30 and 65
- Fitzpatrick Skin Type I-VI
- Moderate to severe wrinkles on the mid and lower face (Lemperle Wrinkle Severity Scale scores 3, 4, or 5)
- Moderate to extreme abdominal skin looseness (Stokes Scale scores 2-4)
- Willingness to sign the informed consent form
You will not qualify if you...
- Pregnant women or nursing mothers
- Dermatosis, open wounds, sores, or irritated skin in the treatment area
- Allergy to stainless steel or to medications used during the procedure such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
- History or presence of any clinically significant bleeding disorder
- Dermatological or autoimmune conditions that may affect treatment outcome including actinic keratosis, raised nevi, rosacea, melasma, active acne, papules/nodules, inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, scleroderma, rheumatoid arthritis, eczema, allergic dermatitis, collagen disorders, or lupus
- Systemic or acute local skin infections such as hepatitis types A-F or HIV
- Use of high-dose blood thinners or anti-coagulants in the past 14 days
- Recent chemotherapy, high-dose corticosteroids, or radiation in the treatment area
- Plastic surgery on the face within the past 12 months or facial scars less than 12 months old
- Injections of dermal fillers, fat, botulinum toxin, or skin treatments in the past 6 months
- Scars less than 6 months old in the treatment area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants receive treatment with the ellacor Micro-Coring Technology device using specially designed hollow coring needles to remove small cores of skin tissue in the mid and lower face.
1 treatment visit
Post-operative Follow-up
Duration - Up to 3 months (90 days)
Participants are monitored through follow-up visits to assess safety and outcomes after the ellacor treatment.
4 scheduled visits on Day 3, Day 7, Day 30, and Day 90, with an additional visit as needed
Trial Site Locations
Total: 1 location
1
Tri Valley Plastic Surgery
Dublin, California, United States, 94568
Actively Recruiting
Loading map...
Research Team
K
Karyn Siemasko, PhD
D
Delia Khayat, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles.
Lisa Gfrerer, Suzanne L Kilmer, Jill S Waibel...
https://pubmed.ncbi.nlm.nih.gov/36262685