Trial Outcomes & Findings for Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone? (NCT NCT05243563)

Last Updated: 2025-06-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

11 participants

Primary outcome timeframe

Completed by the subject at baseline and 6 months.

Results posted on

2025-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Fractionated CO2 Laser Plus Topical Steroids 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Overall Study STARTED	6	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fractionated CO2 Laser Plus Topical Steroids 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fractionated CO2 Laser Plus Topical Steroids n=6 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Completed by the subject at baseline and 6 months.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Skindex-29 Score Increase in Skindex-29 Score	1 Participants	2 Participants
Change in Skindex-29 Score Decrease in Skindex-29 Score	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Scored by the provider at baseline and 6 months

Population: If scale was not completed at either visit, that participant's data was not included in the outcome measure data.

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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=4 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Objective Visual Analog Scale Decrease in score	3 Participants	4 Participants
Change in Objective Visual Analog Scale Increase in score	0 Participants	0 Participants
Change in Objective Visual Analog Scale No change in score	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Administered at baseline and at 6 months by the provider.

Population: When scoring the questionnaire, if the participant did not include a score for both the initial and final question, it was not included.

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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) Decrease in score	4 Participants	2 Participants
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) Increase in score	0 Participants	2 Participants
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) No change in score	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) Decrease in Score	3 Participants	3 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) Increase in Score	1 Participants	2 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) No change in score	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) Decrease in score	3 Participants	2 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) Increase in score	0 Participants	3 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) No change in score	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=5 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) Decrease in score	2 Participants	1 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) Increase in score	0 Participants	1 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) No change in score	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Administered at baseline and 6 months by an investigator to the subject

Population: Only 1 participant was sexually active at both the initial and final visits.

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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=1 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) No change in score	0 Participants	1 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) Decrease in score	0 Participants	0 Participants
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) Increase in score	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fractionated CO2 Laser Plus Topical Steroids n=4 Participants 3 laser treatments at 6 week intervals for 6 months by a single trained operator MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%	Topical Steroids Alone n=4 Participants self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05%
Change in Symptom Subjective Visual Analog Score Decrease in total score	3 Participants	2 Participants
Change in Symptom Subjective Visual Analog Score Increase in total score	1 Participants	1 Participants
Change in Symptom Subjective Visual Analog Score No change in total score	0 Participants	1 Participants

Adverse Events

Fractionated CO2 Laser Plus Topical Steroids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Steroids Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catera Duhon

USA Health

Phone: 251-415-1598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place