New device aims to smooth wrinkles without surgery
NCT ID NCT03573271
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a micro-coring device that removes small pieces of skin to reduce moderate to severe cheek wrinkles. Thirty adults aged 40 to 70 participated. Researchers measured wrinkle improvement at 90 days and tracked any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Micro-coring device (automated skin removal tool)
- What this could lead to
- If it works, this could offer a non-surgical option to reduce facial wrinkles.
- What could go wrong
- This is a small, early study with only 30 participants, so results may not apply to everyone. There is also a risk of side effects like scarring or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Feb 2019
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and females 40-70 years of age * Fitzpatrick Skin Type I to IV as judged by the Investigator. * Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator * Able to provide written informed consent, understand and willing to comply with all study related procedures 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 injections in the areas to be treated * Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices) * 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 * Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study * Treatment with an investigational device or agent within 30 days before treatment or during the study period * Female and pregnant or plan on becoming pregnant during the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, 75231, United States
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Laser and Skin Surgery Center of New York
New York, New York, 10016, United States
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Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816, United States
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Miami Dermatology and Laser Institute
Miami, Florida, 33173, United States
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The Practice of Brian S. Biesman, M.D
Nashville, Tennessee, 37203, United States
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