Trials / Completed
CompletedNCT03774849
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Candela Corporation · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Detailed description
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PicoWay™ 532nm fractional handpiece | PicoWay™ Laser System is picosecond 532/1064/785 laser |
| DEVICE | PicoWay™ 730nm wavelength | PicoWay™ Laser System is picosecond 532/1064/785 laser |
| DEVICE | PicoWay™ 1064nm fractional handpiece | PicoWay™ Laser System is picosecond 532/1064/785 laser |
Timeline
- Start date
- 2018-12-05
- Primary completion
- 2020-11-12
- Completion
- 2020-11-12
- First posted
- 2018-12-13
- Last updated
- 2023-12-01
- Results posted
- 2023-12-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03774849. Inclusion in this directory is not an endorsement.