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

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

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

Study Overview

• Status: Recruiting
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: MonaLisa Touch; Drug: Topical steroid

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Catera Duhon, RN, BSN; Phone Number: 251-415-1598; Email: cduhon@health.southalabama.edu

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Recruiting
      • USA Health Children's and Women's Hospital
      • Contact: Catera Duhon, RN, BSN; Phone Number: 251-415-1598; Email: cduhon@health.southalabama.edu
      • Contact: Charles Hanes, MD
    • Mobile, Alabama, United States, 36604
      • Recruiting
      • USA Health Strata Patient Center
      • Contact: Catera Duhon, RN, BSN; Phone Number: 251-415-1598; Email: cduhon@health.southalabama.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fractionated CO2 laser plus topical steroids; 3 laser treatments at 6 week intervals for 6 months by a single trained operator	Device: MonaLisa Touch; 3 laser treatments at 6 week intervals for 6 months by a single trained operator; Other Names: SMARTXIDE2; Drug: Topical steroid; self-applied topical steroid therapy using clobetasol propionate 0.05%; Other Names: clobetasol propionate
Active Comparator: topical steroids alone; self-applied topical steroid therapy using clobetasol propionate 0.05%	Drug: Topical steroid; self-applied topical steroid therapy using clobetasol propionate 0.05%; Other Names: clobetasol propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.
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.
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.
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
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.
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

Collaborators and Investigators

• Sponsor: University of South Alabama
• Investigators: Principal Investigator: Charles Hanes, MD, Adjunct Associate Professor of Obstetrics and Gynecology; Principal Investigator: Stephen Varner, MD, Associate Professor of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Estimated): April 13, 2025
• Study Completion (Estimated): April 13, 2025

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MonaLisa Touch; fractionated laser; SMARTXIDE2
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: 1731682-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No