CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
The CO2RE® Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04148651
NCT04148651N/ACompleted
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Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus

Candela Corporation·interventional·Posted Nov 1, 2019·Updated Mar 22, 2022

In Brief

A clinical study evaluating The CO2RE® System for Vulvar Lichen Sclerosus. Completed, enrolled 14 participants across 4 sites.

Detailed Summary

Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Lichen Sclerosus
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 1, 2019
Enrollment StartJul 11, 2018
Primary CompletionJul 30, 2020
Study CompletionDec 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.7 years ago

Interventions

The CO2RE® Systemdevice

The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).