Trials / Terminated
TerminatedNCT03454672
A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser
A Prospective, Randomized, Double Arm, Controlled Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles in Comparison With Fractional Laser
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Novoxel Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying thermal (heat) energy to the skin. The study shall compare the safety and the effectiveness of the Tixel with the safety and the effectiveness of a laser device which is currently cleared for marketing in the US.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tixel | Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
| DEVICE | Laser | Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
Timeline
- Start date
- 2018-03-12
- Primary completion
- 2020-09-04
- Completion
- 2020-09-04
- First posted
- 2018-03-06
- Last updated
- 2024-08-23
- Results posted
- 2024-06-20
Locations
2 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03454672. Inclusion in this directory is not an endorsement.