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Histology Evaluation of the CO2RE Device Versus the RePair Device

NCT02147756 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-05-27

No results posted yet for this study

Summary

The purpose of this study is to compare structural changes in the skin caused by the CO2RE device versus the Repair.

Conditions

  • Skin Pigmentation and Texture Disorders.

Interventions

DEVICE

CO2RE

Subjects will be randomly assigned to three different time-points of laser treatment: immediately, 1 week or 4 weeks prior the scheduled abdominoplasty. Subjects will be required to attend between 2 to 3 visits depending on the interval between the treatment and the abdominoplasty procedure. One side of the abdomen will be treated using the CO2RE device and the other side with the RePair device. The investigator will also leave an untreated area (control). Punch biopsies will be obtained before or during the abdominoplasty procedure from the two treated areas (CO2RE and RePair) and one control (un-treated) areas (on the abdominoplasty area) for histological evaluation.

DEVICE

Repair

Sponsors & Collaborators

  • Syneron Medical

    lead INDUSTRY

Principal Investigators

  • Shlomit Mann · Syneron Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-12-31

Countries

  • Argentina

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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 NCT02147756 on ClinicalTrials.gov