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Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two 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 |
|---|---|---|---|
| PicoWay treatment to all subjects | Experimental | Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWay device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two 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 |
|---|---|---|---|---|
| PicoWay device | Device | The PicoWay 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 the PicoWayTM treatment | assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment. | from day 0 up to 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the PicoWayTM | assessed by study investigator during all study visits (treatments and follow-up). | from day 0 up to 13 months |
| efficacy of the PicoWayTM fractional treatment by the investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Jerome M. Garden | Chicago | Illinois | 60611 | United States | ||
| New York Laser & Skin Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26493925 | Background | Hoang Viet M, Derreumaux P, Li MS, Roland C, Sagui C, Nguyen PH. Picosecond dissociation of amyloid fibrils with infrared laser: A nonequilibrium simulation study. J Chem Phys. 2015 Oct 21;143(15):155101. doi: 10.1063/1.4933207. |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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assessed by study investigator during all study visits (starting from the second treatment).
| after 3 weeks up to 13 months |
| Evaluate investigator satisfaction post treatments | assessed by investigator satisfaction post treatments | after 46 weeks and after 52 weeks |
| subject satisfaction post treatments | assessed by subject satisfaction post treatments. | after 46 weeks and after 52 weeks |
| New York |
| New York |
| 10028 |
| United States |
| Dr. Eric F. Bernstein | Ardmore | Pennsylvania | 19003 | United States |