MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus

NCT03665584 | Completed DMC FDA Device

• 1 other identifier: Pro00024516
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lichen Sclerosus; MonaLisa Touch

Outcome Measures

Primary Outcomes (1)

• Inflammatory Infiltration

  A blinded dermatopathologist will evaluate the inflammatory infiltration on biopsy specimens obtained during screening process and after 24-week treatment period.

  26 weeks

Secondary Outcomes (1)

• Changes from Baseline in Clinical Scoring System for Vulvar Lichen Sclerosus

  26 weeks

Study Arms (2)

FxCO2 Laser

ACTIVE COMPARATOR

FxCO2 laser treatment will be performed by scanning across the entire affected anogenital region. The FxCO2 treatment will be performed at baseline and then repeated at 4 week intervals for a total of 5 treatments. The laser parameters change with each treatment: power (18, 20, 22, 24, 26W), dwell time (800, 900, 1000, 1000, 1000us) and spacing (1200, 1100, 1000, 1000, 1000um) in respective order.

Device: FxCO2 Laser

Sham Laser

SHAM COMPARATOR

Sham laser treatment will be performed by scanning across the entire affected anogenital region. The sham treatment will be performed using 4W (power), 400us (dwell time), and 1500um (spacing). The laser has no effect on the vulvar tissue using these parameters.

Device: Sham Laser

Interventions

FxCO2 Laser DEVICE

The FxCO2 laser allows a microablative effect in soft tissue.

FxCO2 Laser

Sham Laser DEVICE

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

Sham Laser

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 18 years or older.
• Have a diagnosis of active lichen sclerosus (Dr. Goldstein will remove a pea size amount of skin (a biopsy) and will do a physical assessment of the vulva area at the beginning of the study to confirm this diagnosis).
• Are willing and able to comply with the study requirements.
• Have a negative pregnancy test prior to enrolling in this study and will use at least one form of birth control during the course of the study if you are sexually active and are of child bearing potential.
• Have at least a 3 out of 10 on a questionnaire that measures the amount of itching you are having.

You may not qualify if:

• Are immunocompromised (have a lowered immune system) (for example, you have been diagnosed with or have a history of lymphoma, AIDS, or Wiskott-Aldrich Syndrome), or have an uncontrolled malignant disease.
• Have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vulva area.
• Have swollen lymph nodes (lymphadenopathy).
• Have any active sexually transmitted diseases on the vulva (herpes, molluscum, condyloma).
• Have been diagnosed with other vulvar dermatologic conditions including lichen planus, psoriasis, lichen simplex chronicus, candidiasis, intraepithelial neoplasia, or carcinoma.
• Are pregnant or breastfeeding.
• If you become pregnant while on the study, you must withdraw from the study.
• Have received an investigational drug within four weeks prior to the study or who plan to use other investigational drugs during the course of this study.
• Have severe medical condition(s) that in the view of the study doctor prohibits participation in the study.
• Have a history of substance abuse or any factor, which limits your ability to cooperate with the study procedures.
• Are uncooperative or are not willing to attend regular visits.
• Have received systemic immunosuppressants (steroids), other systemic therapies or any other systemic therapies known or suspected to have an effect on vulvar lichen sclerosus within 4 weeks prior to participation in the study.
• Have been treated with topical therapy (for example, topical corticosteroids, pimecrolimus, tacrolimus) or any other topical therapies known or suspected to have an effect on vulvar lichen sclerosus or its symptoms within 4 weeks prior to participation in the study.

Sponsors & Collaborators

• Center for Vulvovaginal Disorders: lead
• Gynecologic Cancer Research Foundation: collaborator
• El. En. SpA: collaborator

Study Sites (1)

The Centers for Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• Mitchell L, Goldstein AT, Heller D, Mautz T, Thorne C, Joyce Kong SY, Sophocles ME, Tolson H, Krapf JM. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):979-987. doi: 10.1097/AOG.0000000000004409.

  PMID: 33957648 DERIVED

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew Goldstein, MD

  The Centers for Vulvovaginal Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 11, 2018
• Study Start: August 28, 2018
• Primary Completion: April 15, 2020
• Study Completion: July 14, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)