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Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment

NCT02700204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-09-02

No results posted yet for this study

Summary

This is an open-label, two-arm, histological evaluation study.

Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment:

Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece

All subjects will have biopsies from the treated area:

* at baseline prior to treatment;
* immediately after treatment (within 30 minutes) or 48 hours after treatment;
* 2 months after treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Conditions

  • Dyschromia

Interventions

DEVICE

PicoWay 532nm fractional treatment

is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps

DEVICE

PicoWay 1064nm fractional treatment

is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps

Sponsors & Collaborators

  • Syneron Medical

    lead INDUSTRY

Principal Investigators

  • Arielle Kauvar, MD · NY Laser Skin Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700204 on ClinicalTrials.gov