The CO2RE® System for Vulvar Lichen Sclerosus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-12-17

Brief Summary

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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.

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Detailed Description

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This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser.

Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment.

Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.

Conditions

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Vulvar Lichen Sclerosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CO2RE® Treatment

All eligible subjects will undergo up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser.

Group Type EXPERIMENTAL

The CO2RE® System

Intervention Type DEVICE

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).

Interventions

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The CO2RE® System

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Able to read, understand and sign informed consent for study participation;
2. Female subjects with age 18-80 years;
3. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
4. Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
5. Topical corticosteroid treatment, if any, will be continued during the study period;
6. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
7. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
8. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.

Exclusion Criteria

1. Presence of clinically atypical appearing nevi in the area to be treated;
2. Unexplained vaginal bleeding;
3. Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
4. History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
5. Pelvic organ prolapse \> stage 2;
6. Pregnancy or planning pregnancy during the study;
7. Systemic treatment with immuno-modulatory drugs.
8. Use of vaginal dilators during study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No