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NCT03774849 · ClinicalTrials.gov registry record · NA
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
A NA study of Facial Wrinkles and Benign Pigmented Lesions, sponsored by Candela Corporation.
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 1
- Study location
NCT03774849: Completed NA study of Facial Wrinkles and Benign Pigmented Lesions, sponsored by Candela Corporation.
NCT03774849 is a NA study of Facial Wrinkles and Benign Pigmented Lesions that has completed, run by Candela Corporation. The registered enrollment target is 115 participants, above the 68-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (69% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03774849, a NA study of Facial Wrinkles and Benign Pigmented Lesions, has completed, sponsored by Candela Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Primary Outcome
9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis \[individual papules with yellow translucency under direct lighting\] and dyschromia) 7-9 Severe (multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis)
Conditions Studied
Interventions
- DEVICE PicoWay™ 532nm fractional handpiece
- DEVICE PicoWay™ 730nm wavelength
- DEVICE PicoWay™ 1064nm fractional handpiece
Study Locations (1)
Massachusetts
- Syneron Candela Institute for Excellence - Wayland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2020-11-12 |
| Phase | NA |
What the finished NCT03774849 record still lists
NCT03774849 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 68-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (69% higher).
The record links to 2 conditions, with Facial Wrinkles appearing as the primary indexed condition, and to 3 interventions - of which PicoWay™ 532nm fractional handpiece is the first listed.
NCT03774849 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03774849 about?
NCT03774849 is a clinical study titled "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.
What is the current status of trial NCT03774849?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2018-12-05. Estimated completion is 2020-11-12.
What conditions does trial NCT03774849 study?
This clinical trial studies the following conditions: Facial Wrinkles, Benign Pigmented Lesions.
What interventions are being tested in trial NCT03774849?
The interventions under investigation include: PicoWay™ 532nm fractional handpiece (DEVICE), PicoWay™ 730nm wavelength (DEVICE), PicoWay™ 1064nm fractional handpiece (DEVICE).
Who is sponsoring clinical trial NCT03774849?
This trial is sponsored by Candela Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03774849 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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