Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Lax… (NCT03583918) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck
United States50 participantsStarted 2017-06-01
Plain-language summary
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fitzpatrick Skin Type 1, 2, or 3 as judged by the Investigator
* Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)
* Cheek fold lines \>2
* Upper lip lines \>3
* Nasolabial Folds \>3
* Marionette lines \>3
* Labiomental crease \>3
* Corner of the mouth lines \>3
* Periocular lines \>3
* Able to provide written informed consent, understand and willing to comply with all study related directions from investigator 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 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
* Histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale