NCT05243563

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

Terminated Phase 2, PHASE3 Results posted Last updated 18 June 2025

What this trial tests

Phase 2, PHASE3 trial testing MonaLisa Touch in Vulvar Lichen Sclerosus in 11 participants. Terminated before completion.

Timeline

13 April 2022

Primary endpoint
3 June 2024

3 June 2024

Quick facts

Lead sponsor	University of South Alabama
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	13 April 2022
Primary completion	3 June 2024
Estimated completion	3 June 2024
Sites	2 locations across United States

Drugs / interventions tested

• MonaLisa Touch
• Topical steroid — full drug profile →

Conditions studied

• Vulvar Lichen Sclerosus — all drugs for Vulvar Lichen Sclerosus →

Sponsor

University of South Alabama

Who can join

Adults 18 to 85, female only, with Vulvar Lichen Sclerosus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Skindex-29 Score Primary · Completed by the subject at baseline and 6 months.

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.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	3
Topical Steroids Alone	3
Fractionated CO2 Laser Plus Topical Steroids	1
Topical Steroids Alone	2

Change in Objective Visual Analog Scale Secondary · Scored by the provider at baseline and 6 months

Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	3
Topical Steroids Alone	4
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	0
Fractionated CO2 Laser Plus Topical Steroids	1
Topical Steroids Alone	0

Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) Secondary · Administered at baseline and at 6 months by the provider.

This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	4
Topical Steroids Alone	2
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	2
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	1

Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) Secondary · Administered at baseline and at 6 months by the provider.

A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	3
Topical Steroids Alone	3
Fractionated CO2 Laser Plus Topical Steroids	1
Topical Steroids Alone	2
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	0

Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) Secondary · Administered at baseline and at 6 months by the provider.

A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	3
Topical Steroids Alone	2
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	3
Fractionated CO2 Laser Plus Topical Steroids	1
Topical Steroids Alone	0

Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) Secondary · Administered at baseline and at 6 months by the provider.

A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	2
Topical Steroids Alone	1
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	1
Fractionated CO2 Laser Plus Topical Steroids	2
Topical Steroids Alone	3

Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) Secondary · Administered at baseline and 6 months by an investigator to the subject

A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	1
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	0
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	0

Change in Symptom Subjective Visual Analog Score Secondary · Administered at baseline and 6 months by an investigator to the subject

This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms.

Group	Value	95% CI
Fractionated CO2 Laser Plus Topical Steroids	3
Topical Steroids Alone	2
Fractionated CO2 Laser Plus Topical Steroids	1
Topical Steroids Alone	1
Fractionated CO2 Laser Plus Topical Steroids	0
Topical Steroids Alone	1

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication 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