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. · 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.
Exclusion Criteria:
Radiofrequency Device Only:
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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Cynosure, Inc.