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MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus

NCT03665584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-12

No results posted yet for this study

Summary

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.

The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system.

Recently, microablative fractional CO 2 laser treatment (FxCO 2 ) (SmartXide 2 V 2 LR laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS. Specifically, two small studies demonstrated that FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO 2 treatment may stimulate tissue healing in LS. Furthermore, by reducing inflammation, the clinical symptoms of LS, such as intense itching and burning, were improved. While these studies showed good success, these studies were limited because of their small size and lack of sham (fake treatment) control.

The purpose of this study is to look at the efficacy (how well it works) and the safety of the FxCO 2 laser treatment (laser energy emitted) for LS as compared to a sham treatment (very minimal laser energy will be emitted).

Conditions

  • Lichen Sclerosus

Interventions

DEVICE

FxCO2 Laser

The FxCO2 laser allows a microablative effect in soft tissue.

DEVICE

Sham Laser

The Sham laser will be used on the participants who receive the sham treatment.

Sponsors & Collaborators

  • Gynecologic Cancer Research Foundation

    collaborator OTHER

  • El. En. SpA

    collaborator INDUSTRY

  • Center for Vulvovaginal Disorders

    lead OTHER

Principal Investigators

  • Andrew Goldstein, MD · The Centers for Vulvovaginal Disorders

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2020-04-15
Completion
2020-07-14
FDA Device
Yes

Countries

  • United States

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 NCT03665584 on ClinicalTrials.gov