Clinical trial NCT05096247: Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
Official title: Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Benign Pigmented Lesions
Benign Vascular Lesions
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.
Primary purpose: TREATMENT

Brief summary: The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.


Eligibility criteria: Inclusion Criteria:

* A healthy male or female 18 years of age or older.
* 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:

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* 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.

Exclusion Criteria for Icon Treatments Only:

* 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.

Primary outcomes:
measure: Number of Subjects Who Noticed Improvement
timeFrame: 12 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Westford
country: United States
facility: Cynosure
state: Massachusetts
city: Portsmouth
country: United States
facility: Excellent Vision
state: New Hampshire
city: Huntersville
country: United States
facility: Saluja Cosmetic and Laser Center
state: North Carolina
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References:
citation: 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.