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New device aims to smooth wrinkles by removing tiny skin cores

NCT ID NCT03228641

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a micro-coring device on 45 people to see if it can safely reduce wrinkles and skin laxity in the face. The device uses tiny hollow needles to remove small cores of skin, which triggers the body to produce new collagen and elastin. The goal was to improve wrinkle and laxity scores by at least one grade.

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
What this could lead to
If it works, this could offer a non-surgical option to reduce facial wrinkles and sagging skin.
What could go wrong
This is a small pilot study with only 45 people, so results may not apply to everyone. The device is still experimental and may not work as well as expected.

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

45 people

The number who actually took part.

Started

Jun 2016

Finished

Aug 2017

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * 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 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 * 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

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Conditions

The condition(s) this trial relates to.

Facies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dr A Jay Burns Cosmetic Surgery

    Dallas, Texas, 75231, United States

  • Laser & Skin Center of Northern CA

    Sacramento, California, 95816, United States

  • Laser & Skin Surgery Center of NY

    New York, New York, 10016, United States

  • Miami Dermatology and Laser Institute

    Miami, Florida, 33173, United States

  • Nashville Center for Laser & Facial Surgery

    Nashville, Tennessee, 37203, United States

  • SkinCare Physicians

    Chestnut Hill, Massachusetts, 02467, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.