Status:
COMPLETED
Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity
Lead Sponsor:
Cytrellis Biosystems, Inc.
Conditions:
Wrinkle
Facial and Neck Skin Laxity
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and eff...
Detailed Description
This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess s...
Eligibility Criteria
Inclusion
- Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
- One or more of the following conditions assessed by Investigator using provided Severity Scales:
- Nasolabial fold severity at rest ≥2 and ≤4;
- Marionette line prominence at rest ≥2 and ≤4;
- Oral commissure drooping at rest ≥2 and ≤4;
- Jawline sagging at rest ≥2 and ≤4 .
- Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.
Exclusion
- 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 or synthetic material injections in the areas to be treated
- Injection of FDA-approved dermal fillers in the past two years
- Injection of fat in the past year
- History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
- History of treatment with non-ablative laser in the past 6 months
- History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
- 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
- Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
- History of drug and/or alcohol abuse
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03228641
Start Date
June 1 2016
End Date
April 30 2018
Last Update
June 11 2018
Active Locations (5)
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1
Laser & Skin Center of Northern CA
Sacramento, California, United States, 95816
2
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
3
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
4
Nashville Center for Laser & Facial Surgery
Nashville, Tennessee, United States, 37203