An interventional study of Intense pulsed light. and Radiofrequency microneedling device in Dermatologic Conditions, sponsored by Cynosure, Inc.. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Cynosure, Inc. (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment
The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.
Up to 50 subjects will be enrolled at 1 study center. Subjects will be enrolled into 4 groups: Group A, Group B, Group C, or Group D. Subjects may enroll in more than one group, however the last treatment in the previous group would be at least 30 days before the subject is enroll in the next group if treatment area is the same.
Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.
First submitted before Cynosure, Inc. became part of Cynosure Lutronic, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Radiofrequency Device Only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA.
Device: Intense pulsed light.
Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA.
Device: Radiofrequency microneedling device
Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA.
Device: Radiofrequency device
Group D will receive combination treatments and will be treated with 2 or more of the study devices.
Device: Intense pulsed light. · Device: Radiofrequency microneedling device · Device: Radiofrequency device · Device: Combined energy devices
The intense pulsed light (IPL) will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
The microneedling device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
The radio frequency device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
The combined energy devices will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
Maximum pain reported during treatment.
The maximum pain during treatment per each device will be reported on a scale of 0(none) to 10 (maximum intolerable pain). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device).
Time frame: procedure (during device treatment)]
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