Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions
Conditions
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.
Interventions
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Noticed Improvement | 12 week follow up | Subjects graded themselves on a scale ranging from Worsened to Very Much Improved at the follow up visit. The number of subjects who graded themselves as Improved was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 35 |
| Total | 48 |
Baseline characteristics
| Characteristic | Treatment With RF Device | Treatment With IPL and RF Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 33 Participants | 45 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type I | 0 Participants | 3 Participants | 3 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type II | 6 Participants | 11 Participants | 17 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type III | 5 Participants | 20 Participants | 25 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type IV | 2 Participants | 1 Participants | 3 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type V | 0 Participants | 0 Participants | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 12 Participants | 35 Participants | 47 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 12 Participants | 32 Participants | 44 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 35 |
| other Total, other adverse events | 13 / 13 | 5 / 35 |
| serious Total, serious adverse events | 0 / 13 | 0 / 35 |
Outcome results
Primary
Number of Subjects Who Noticed Improvement
Subjects graded themselves on a scale ranging from Worsened to Very Much Improved at the follow up visit. The number of subjects who graded themselves as Improved was reported.
Time frame: 12 week follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With RF Device | Number of Subjects Who Noticed Improvement | 10 Participants |
| Treatment With IPL and RF Device | Number of Subjects Who Noticed Improvement | 34 Participants |