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Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.
This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all subjects | Experimental | will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoWayTM | Device | The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis. | assessed by blinded evaluators. | day 0 up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator | Percentage of subjects with improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator | from 3 weeks up to 9 months |
| Safety of PicoWay treatment by Adverse events record during all study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric F Bernstein, M.D. | Main Line Center for Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jerome M. Garden | Chicago | Illinois | 60611 | United States | ||
| Arielle N. Kauvar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23016529 | Background | Bloom BS, Emer J, Goldberg DJ. Assessment of safety and efficacy of a bipolar fractionated radiofrequency device in the treatment of photodamaged skin. J Cosmet Laser Ther. 2012 Oct;14(5):208-11. doi: 10.3109/14764172.2012.724534. |
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assessed by study investigator during all study |
| day 0 up to 9 months |
| Evaluate investigator satisfaction assessed by questionnaire | by questionnaire | from 24 weeks up to 36 weeks |
| Evaluate subject satisfaction assessed by questionnaire | by questionnaire | from 24 weeks up to 36 weeks |
| New York |
| New York |
| 10028 |
| United States |
| Eric F. Bernstein | Ardmore | Pennsylvania | 19003 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |