New needle treatment smooths cellulite dimples
NCT ID NCT06283056
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tested a device that uses tiny needles and radiofrequency energy to treat cellulite on the legs. 48 women received the treatment to reduce the appearance of dimples and improve skin tightness. The goal was to see if the treatment is safe and effective for smoothing skin.
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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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48 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Apr 2025
- 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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18 to 65 years
- Sex
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Female participants only
- 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: * Female subjects aged 18-65 (inclusive) * BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese). * Subject having cellulite grade 1-4 as graded using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)7. * The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography). * The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods (i.e liposuction, any cellulite/circumference reduction treatments using medical devices, etc.) in the treatment area for the last 6 months and during the entire study period. * Females of Childbearing potential must be using an approved method of birth control. Subjects who are capable of becoming pregnant will undergo a urine pregnancy test. Exclusion Criteria: * Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. * Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance. * Known sensitivity/allergy to Lidocaine * Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles. * Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases. * Pregnancy and nursing or lactating. * History of bleeding coagulopathies or use of anticoagulants. * Chronic or current use of NSAIDs or other anti-inflammatory therapies (e.g., Ibuprofen, etc.) * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. * Any uncontrolled medical condition (i.e., endocrine disorders, diabetes, thyroid disfunction or hormonal virilization) that in the opinion of the investigator, the subject's safety may be compromised. * Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * Use of Isotretinoin (Accutane®) within 6 months prior to treatment. * Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing. * Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the subject or quality of the study data. * Current, or past participation in a clinical trial within the past 30 days.
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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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Dallas Plastic Surgeon
Dallas, Texas, 75225, United States
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Dermatology & Laser Surgery Center of New York
New York, New York, 10028, United States
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