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Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

NCT03063684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-08-06

No results posted yet for this study

Summary

The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy and in vulvar lichen sclerosus by means of histological and immuno-histochemical characterization of the epithelial layers and markers of tissue aging. The tissue characterization will be performed by biopsies of the vaginal or vulvar tissue at three different points of time: prior to treatment, two weeks after the third and last treatment, and one year after the last treatment.

Conditions

  • Vaginal Atrophy
  • Lichen Sclerosus

Interventions

DEVICE

Fractional / Pixel CO2 Laser

The laser energy is transferred in a fractioned manner: the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2, so the laser rays hit the tissue in small spots. For gynecological applications, the treatment is performed by a transducer, which was specifically designed for vaginal application.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-12-30
Completion
2019-04-28

Countries

  • Israel

Study Locations

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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 NCT03063684 on ClinicalTrials.gov