Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
NCT ID: NCT05096247
Last Updated: 2023-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2021-09-03
2022-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with RF Device
Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
TempSure
This device is an RF device.
Treatment with IPL and RF Device
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
TempSure
This device is an RF device.
Icon
This device works with IPL (Intense Pulsed Light) handpieces.
Interventions
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TempSure
This device is an RF device.
Icon
This device works with IPL (Intense Pulsed Light) handpieces.
Eligibility Criteria
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Inclusion Criteria
* Agrees to be treated with the TempSure device.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion Criteria
* The subject has a cut, wound, or infected skin on the area to be treated.
* The subject is on local, oral, or systemic anesthetic agents.
* The subject has nerve insensitivity to heat in the treatment area.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
* The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.
* The subject has a medical condition or is receiving treatment that significantly compromise healing response.
* The subject has a history of light-induced seizures.
* The subject has a history of skin photosensitivity disorders.
* The subject has a history of hypertrophic scars or keloid formation.
* The subject has a history of radiation therapy in area to be treated.
18 Years
ALL
No
Sponsors
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Cynosure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Civiok
Role: STUDY_DIRECTOR
Cynosure, Inc.
Locations
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Cynosure
Westford, Massachusetts, United States
Excellent Vision
Portsmouth, New Hampshire, United States
Saluja Cosmetic and Laser Center
Huntersville, North Carolina, United States
Countries
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References
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Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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7027-PM01-2021
Identifier Type: -
Identifier Source: org_study_id