New radiofrequency treatment aims to tighten sagging skin without surgery
NCT ID NCT07187297
First seen Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 5 times
Summary
This study is testing a device called Thermage FLX that uses radiofrequency energy to improve wrinkles and tighten loose skin on the neck, abdomen, upper arms, and face. About 164 adults with mild-to-moderate skin laxity or wrinkles will receive the treatment and be followed for 180 days. The goal is to see if the treatment safely reduces wrinkles and lifts sagging tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Thermage FLX radiofrequency device
- What this could lead to
- If it works, this could offer a non-surgical option to reduce wrinkles and tighten loose skin on the neck, abdomen, upper arms, and face.
- What could go wrong
- This is a relatively small study (164 people) and results may not apply to everyone. Radiofrequency treatments can cause temporary redness or swelling, and the effect may be modest or not last long.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- 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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30 to 60 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: * Be an adult female or male, ≥30 - ≤60 years of age. Have mild-to-moderate skin laxity of the neck, abdomen, upper arms, and/or face, and/or mild-to-moderate lines and/or wrinkles of the neck and/or face assessed as follows: Neck: Mild-to-moderate neck skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9) Mild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9) Abdomen: Mild-to-moderate abdomen skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0-3) Upper arms: Mild to moderate upper arms skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale Face: Mild-to-moderate facial skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9) Mild-to-moderate facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9) Females of childbearing potential must have a negative urine pregnancy test. Females who have experienced menarche and who are not postmenopausal (either confirmed via FSH testing or who have not menstruated for 2 years or more without an alternative medical cause) or surgically sterile will be considered of childbearing potential. Females of childbearing potential must agree to use an acceptable method of birth control for the duration of the study. Acceptable methods of birth control are oral and other systemic contraceptives, condoms only, intrauterine device, double-barrier methods, bilateral tubal ligation, partner vasectomy, and abstinence. Have no clinically abnormal findings based on the medical history as determined by the study investigator. Be able to follow the study instructions, be available on the specific required study visit days, and be willing to complete all study visit procedures and assessments. Understand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment. Agree to not undergo excluded procedures (i.e., energy-based device treatments, injectables, or plastic surgery) on the study treatment areas for the duration of study. Participant has a body mass index (BMI) ≤30. Exclusion Criteria: * Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study. Participant has given birth within 3 months prior to the screening visit. Participant has an anticipated need for procedures, surgery, overnight hospitalization, or other events that would prevent the participant from making the required visits during the study. Participant has a pacemaker, internal defibrillator, or other implanted electronic device. Participant has an implant in the target treatment zone(s). Participant has had radiation therapy in the target treatment zone(s). Participant has had 1 or more prior cosmetic procedures in the target treatment zone(s) including: Thermage or any energy-based device procedure, derm abrasion, or chemical peel on any treatment area within 6 months prior to the screening visit. Short-acting neurotoxins within 6 months prior to the screening visit. Long-acting neurotoxins within 9 months prior to the screening visit. Hyaluronic acid filler ≤1 year prior to the screening visit. Semi-permanent or permanent fillers at any time prior to the screening visit. Plastic surgery within 1 year prior to the screening visit.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Locations
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Chicago Cosmetic Surgery and Dermatology
RECRUITINGChicago, Illinois, 60654, United States
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Cosmetic Laser Dermatology
RECRUITINGSan Diego, California, 92121, United States
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Cosmetic Laser Dermatology
RECRUITINGSan Diego, California, 92121, United States
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Dermatology and Laser Surgery Center
RECRUITINGHouston, Texas, 77004, United States
Contact Email: •••••@•••••
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Laser & Skin Surgery Center of Northern California
RECRUITINGSacramento, California, 95816, United States
Contact Email: •••••@•••••
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SkinCare Physicians
RECRUITINGChestnut Hill, Massachusetts, 02467, United States
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Union Square Laser Dermatology
RECRUITINGNew York, New York, 10003, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a wrinkle injection smooth away the signs of aging?
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- Neck wrinkle fix: filler study compares two injection methods
- Chest wrinkle filler put to the test — will it interfere with breast cancer screening?
- Can sound waves tighten loose skin after weight loss?
- Sound waves and muscle zaps aim to tighten sagging skin without surgery