Laser Treatment for Vulvar Lichen Sclerosus

NCT04134494 | Terminated Results FDA Device

• 1 other identifier: 2019P000344
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus. Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment. Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus. The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.

Conditions

Vulvar Lichen Sclerosus

Keywords

Massachusetts residents

Outcome Measures

Primary Outcomes (1)

• Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment

  The baseline depth of lichen sclerosus will be based on the results of the clinical biopsy performed before study participation. The investigators will use the study biopsy collected at the follow-up visit three months after the last treatment to determine resolution of disease or, if disease persists, to what depth. The biopsies will therefore serve as an objective means to determine effective treatment of disease.

  From enrollment to 3 months after the last laser treatment

Secondary Outcomes (4)

• Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)

  From enrollment to 3 months after last laser treatment

• Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)

  3 months after last laser treatment

• Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)

  From enrollment to 3 months after last laser treatment

• Satisfaction With Treatment Using a Participant Satisfaction Questionnaire

  3 months after last laser treatment

Study Arms (1)

Intervention

EXPERIMENTAL

Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart

Device: Ablative Fractional 2940 nm Laser

Interventions

Ablative Fractional 2940 nm Laser DEVICE

* Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.

Intervention

Eligibility Criteria

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

You may qualify if:

• Female
• Aged 18 years old or older
• Biopsy-proven active vulvar lichen sclerosus
• Characteristic changes of vulvar lichen sclerosus on gynecological exam
• Self-reported indication of one or more of the following symptoms of lichen sclerosus
• Dryness
• Itching
• Burning
• Bleeding
• Blistering
• Soreness
• Easily bruises
• Easily tears
• Ulcerated lesions
• Painful intercourse

You may not qualify if:

• Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment
• Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment
• Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome)
• History of uncontrolled malignant disease
• Additional genital skin disease
• Known allergy or intolerance to topical anesthesia
• Known history of connective tissue disease
• Known propensity for keloid formations

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Sciton: collaborator

Study Sites (1)

BIDMC

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Lasers

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Roger Lefevre
• Organization: BIDMC

rlefevre@bidmc.harvard.edu

6176674070

Study Officials

• Roger Lefevre, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used as all patients will receive the treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics, Gynecology and Reproductive Biology

Model Details: The objective was to enroll a single group of 30 patients with biopsy-proven Lichen sclerosus will be treated on a monthly basis for 3 months. Biopsy to be repeated at month #6. The biopsy from before treatment will be compared with biopsies after treatment. Enrollment ended early.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 22, 2019
• Study Start: January 1, 2020
• Primary Completion: May 27, 2022
• Study Completion: December 31, 2022
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Locations

US (1)