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

Vulvar Lichen Sclerosus Clinical Trial

Official title:

A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243563
• Other study ID #: 1731682-3
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 13, 2022
• Est. completion date: April 13, 2025

Study information

• Verified date: December 2023
• Source: University of South Alabama
• Contact: Catera Duhon, RN, BSN
• Phone: 251-415-1598
• Email: cduhon[@]health.southalabama.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: April 13, 2025
• Est. primary completion date: April 13, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

Device:
• MonaLisa Touch
3 laser treatments at 6 week intervals for 6 months by a single trained operator

Drug:
• Topical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%

Locations

Country	Name	City	State
United States	USA Health Children's and Women's Hospital	Mobile	Alabama
United States	USA Health Strata Patient Center	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Objective Visual Analog Scale	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.	Scored by the provider at baseline and 6 months
Secondary	Global Subjective Visual Analog Scale	Providers will use this scale to subjectively assess improvement in vulvar appearance. The provider will grade the improvement from baseline on a 6 point scale, with 0 being "much worse" and 5 being "much better".	Scored by the provider at 6 months
Secondary	Change in Vulvovaginal Symptoms Questionnaire (VSQ) score (Total Score)	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.	Administered at baseline and at 6 months by the provider.
Secondary	Change in Vulvovaginal Symptoms Questionnaire score (Symptoms Component only)	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.	Administered at baseline and at 6 months by the provider.
Secondary	Change in Vulvovaginal Symptoms Questionnaire score (Emotion Component only)	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.	Administered at baseline and at 6 months by the provider.
Secondary	Change in Vulvovaginal Symptoms Questionnaire score (Life Impact Component only)	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.	Administered at baseline and at 6 months by the provider.
Secondary	Change in Vulvovaginal Symptoms Questionnaire score (Sexual Impact Component only)	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.	Administered at baseline and 6 months by an investigator to the subject
Secondary	Patient reported satisfaction with treatment	5 point scale of satisfaction: 0 = very unsatisfied, 1 = unsatisfied, 2 = neutral, 3 = satisfied, 4 = very satisfied	Administered by an investigator to the subject at 6 months.
Secondary	Change in symptom subjective visual analog score	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.	Administered at baseline and 6 months by an investigator to the subject