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New skin device shows promise for wrinkle and pigment reduction

NCT ID NCT06645366

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed trial tested the BTL-785F device on 39 healthy adults over 30 who wanted better skin on their face and neck. Participants received three treatments, each lasting 20–60 minutes, spaced 2–6 weeks apart. The goal was to see if the device could improve skin texture, reduce wrinkles, pigmentation, and laxity, as measured by photos and patient satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BTL-785F device (a skin treatment device using a specialized tip and applicator)
What this could lead to
If it works, this could offer a non-invasive option for improving skin texture and reducing wrinkles, pigmentation, and laxity on the face and neck.
What could go wrong
This is a small, completed trial with no phase designation, so results may not apply to everyone. The device may cause side effects like redness or scabbing, and long-term benefits are unknown.

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

39 people

The number who actually took part.

Started

Jun 2024

Finished

Apr 2025

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

22 years and older

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: * Healthy male or female subjects over 30 years of age seeking treatment for improvement in skin quality and texture on face and neck * Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form * Subjects willing and able to abstain from partaking in any facial or neck treatments other than the study procedure during study participation * Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face and neck without makeup taken Exclusion Criteria: * Local bacterial or viral infection in the area to be treated * Local acute inflammation in the area to be treated * Impaired immune system caused by any immunosuppressive illness, disease or medication * Isotretinoin and tretinoin-containing medication use in the past 12 months * Skin related autoimmune diseases * Radiation therapy and/or chemotherapy * Poor healing and unhealed wounds in the treatment area * Metal implants near the treatment area or neutral electrode * Permanent implant in the treated area * Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body * Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles * History of any type of cancer * Active collagen diseases * Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, and thrombosis)1 * Pregnancy/nursing or IVF procedure * History of bleeding coagulopathies, use of anticoagulants * Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea * Any surgical procedure in the treatment area within the last three months or before complete healing * Poorly controlled endocrine disorders, such as diabetes * Tuberculosis * Hepatitis * Febrile conditions * Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period * History of skin disorders, keloids, abnormal wound healing and dry or fragile skin * Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks * Neurotoxin/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment * Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session * Treating over tattoo or permanent make-up * Treating over eyelids or the lips * Patients with allergy to anesthetics * Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment * Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise 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

  • AboutSkin Dermatology & DermSurgery

    Greenwood Village, Colorado, 80111, United States

  • Boyd Beauty

    Birmingham, Michigan, 48009, United States

  • Capital Laser & Skin Care

    Chevy Chase, Maryland, 20815, United States

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