NCT03665584

MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus

Completed NA Last updated 12 November 2020

What this trial tests

NA trial testing FxCO2 Laser in Lichen Sclerosus in 40 participants. Completed in 14 July 2020.

Timeline

28 August 2018

Primary endpoint
15 April 2020

14 July 2020

Quick facts

Lead sponsor	Center for Vulvovaginal Disorders
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	28 August 2018
Primary completion	15 April 2020
Estimated completion	14 July 2020
Sites	1 location across United States

Drugs / interventions tested

• FxCO2 Laser
• Sham Laser

Conditions studied

• Lichen Sclerosus — all drugs for Lichen Sclerosus →

Sponsor

Center for Vulvovaginal Disorders — full company profile →

Who can join

18 and older, female only, with Lichen Sclerosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lichen sclerosus: The 2023 update.
   De Luca DA, Papara C, Vorobyev A, Staiger H, et al · · 2023 · cited 94× · PMID 36873861 · DOI 10.3389/fmed.2023.1106318
2. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial.
   Mitchell L, Goldstein AT, Heller D, Mautz T, et al · · 2021 · cited 30× · PMID 33957648 · DOI 10.1097/aog.0000000000004409
3. Treatment Options in Vulvar Lichen Sclerosus: A Scoping Review.
   Singh N, Mishra N, Ghatage P. · · 2021 · cited 13× · PMID 33786234 · DOI 10.7759/cureus.13527