Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

NCT05243563 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 1731682-3
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.

Conditions

Vulvar Lichen Sclerosus

Keywords

MonaLisa Touch; fractionated laser; SMARTXIDE2

Outcome Measures

Primary Outcomes (1)

• Change in Skindex-29 Score

  The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.

  Completed by the subject at baseline and 6 months.

Secondary Outcomes (7)

• Change in Objective Visual Analog Scale

  Scored by the provider at baseline and 6 months

• Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)

  Administered at baseline and at 6 months by the provider.

• Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)

  Administered at baseline and at 6 months by the provider.

• Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)

  Administered at baseline and at 6 months by the provider.

• Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)

  Administered at baseline and at 6 months by the provider.

Study Arms (2)

Fractionated CO2 laser plus topical steroids

EXPERIMENTAL

3 laser treatments at 6 week intervals for 6 months by a single trained operator

Device: MonaLisa Touch; Drug: Topical steroid

topical steroids alone

ACTIVE COMPARATOR

self-applied topical steroid therapy using clobetasol propionate 0.05%

Drug: Topical steroid

Interventions

MonaLisa Touch DEVICE

3 laser treatments at 6 week intervals for 6 months by a single trained operator

Also known as: SMARTXIDE2

Fractionated CO2 laser plus topical steroids

Topical steroid DRUG

self-applied topical steroid therapy using clobetasol propionate 0.05%

Also known as: clobetasol propionate

Fractionated CO2 laser plus topical steroids; topical steroids alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores \>21

You may not qualify if:

• prior vaginal mesh or pelvic radiation
• active genital infection
• Current or past gynecologic malignancy

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (2)

USA Health Children's and Women's Hospital

Mobile, Alabama, 36604, United States

Location

USA Health Strata Patient Center

Mobile, Alabama, 36604, United States

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Steroids; Clobetasol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Betamethasone; Steroids, Fluorinated

Results Point of Contact

• Title: Catera Duhon
• Organization: USA Health

cduhon@health.southalabama.edu

251-415-1598

Study Officials

• Charles Hanes, MD

  Adjunct Associate Professor of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Stephen Varner, MD

  Associate Professor of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: April 13, 2022
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

US (2)