Clinical trial NCT05243563
Conditions: Vulvar Lichen Sclerosus
Keywords: MonaLisa Touch fractionated laser SMARTXIDE2
Sponsor: University of South Alabama
Start date: 2022-04-13; Completion date: 2024-06-03
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

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.

Arms: arm 1: 3 laser treatments at 6 week intervals for 6 months by a single trained operator arm 2: self-applied topical steroid therapy using clobetasol propionate 0.05%
Interventions: intervention 1: MonaLisa Touch intervention 2: Topical steroid
Intervention descriptions: intervention 1: 3 laser treatments at 6 week intervals for 6 months by a single trained operator intervention 2: self-applied topical steroid therapy using clobetasol propionate 0.05%

Protocol documents:
Prot_000.pdf: 
Version 1: October 8, 2021 
 
Does topical steroids plus Mona Lisa Laser improve symptoms of Lichen Sclerosus compared to 
treatment with topical steroids alone? 
 
 
Principal Investigator: Charles Hanes, MD  
 
Co Investigators: Stephen Varner, MD, Hayden Kassels, MD, Catera Duhon, RN, BSN  
 
Research Site: University of South Alabama Strada Patient Care Clinic  
 
Institution: University of South Alabama Obstetrics and Gynecology Department  
 
Funding Sponsor: No funding available  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Version 1: October 8, 2021 
 
Introduction 
Vulvar Lichen sclerosus is a common benign dermatosis which causes pain and itching. Topical Steroids 
have been the main treatment modality. A recent study showed that fractionated CO2 laser treatment is 
non inferior and actually showed statistically significant improvement in subjective symptoms compared 
to clobetasol propionate steroid cream with no serious safety or adverse events. With steroids having a 
protective cancer benefit on lichen sclerosus, we hypothesize that steroids in additional to mona lisa 
laser will provide greater symptom relief while still providing the benefits of steroids on lichen sclerosus. 
This study will be following the clinical research protocol created and Good Clinical Practice standards 
and associated federal regulations.  
 
 
Study Objectives  
To assess the efficacy of laser with use of topical steroid versus topical steroid treatment alone for lichen 
sclerosus symptoms 
 
 
Study Design  
Primary Outcome: The primary outcome will be change in mean Skindex 29 score at 6 months.  
 
Secondary Outcomes: Quality of life measurements using a subjective visual analog scale for 
bothersome vulvar symptoms, vulvovaginal symptoms questionnaire, and a global impression of 
improvement and satisfaction at six months. Secondary objective measures include provider assessment 
of vulvar appearance using an objective visual analog scale. 
 
 
Subject Selection and Withdrawal 
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, or active genital infection 
 
Subject Recruitment and Screening: The patients will be recruited by word of mouth in our OB/GYN 
clinic. Inclusion criteria includes biopsy proven lichen sclerosus.  
 
Early Withdrawal of Subjects  
Subjects that have any adverse effects, including worsening lichen sclerosus, severe irritation or any 
other safety reasons may withdraw from the study. Also subjects that do not adhere to the protocol 
may also be withdrawn. The subjects will also have to option to withdraw if they request.  
 
Study Procedures 
Risks: Risks to the subjects are minimal. The laser has been previously used for lichen sclerosus 
treatment and has been overall tolerated well. Potential side effects include vaginal irritation.  
 
Adverse Event 
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or 
the study procedure. An untoward medical occurrence includes any new, undesirable medical experience 


Version 1: October 8, 2021 
 
or worsening of pre-existing condition, which occurs at any point from the start of treatment to the final 
visit.  
 
Expected Morbidity/Anticipated Adverse Events 
An expected morbidity/procedural complication is defined as an AE that is known to be common or usual 
in nature, severity, or incidence during treatment. Post laser vaginal mild irritation is expected and will 
not be documented as an adverse event unless the investigator considers the pain or fever to exceed that 
normally anticipated during laser treatment.  
 
 
Serious Adverse Effect  
A serious adverse event is any AE that:  
• 
Led to a death 
• 
Led to a serious deterioration in the health of the subject that either resulted in:  
o 
A congenital deformity or abnormality 
o 
A life-threatening illness or injury  
o 
A permanent impairment of a body structure or a body function  
o 
In patient hospitalization or prolongation of existing hospitalization  
o 
Medical or surgical intervention to prevent life threatening illness or injury; or permanent 
impairment of a body structure or a body function  
 
 
Note: “Death” should not be reported as an AE. The cause of death should be reported as the AE. The 
only exception is “Sudden Death” when the cause is unknown.  
 
Adverse Device Effect  
An adverse device effect is any untoward and unintended response to a medical device. This includes 
any event arising from insufficiencies or inadequacies in the instructions for use or the deployment of 
the device. It also includes any event that is a result of user error.  
 
Serious Adverse Device Effect (SADE)  
A serious adverse device effect is an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event or that might have led to any of these consequences if suitable 
action had not been taken or intervention had not been made or if circumstances had been less 
opportune. Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
 
Severity of Adverse Effect  
It is the investigator’s responsibility to assess the severity of an AE. A change in severity may constitute a 
new reportable AE.  
 
The following guideline should be used to determine the severity of each adverse event:  
• 
Mild: awareness of experience, but easily tolerated. No medical intervention required.  
• 
Moderate: enough discomfort to interfere with usual activities. Medical Intervention required.  
• 
Severe: inability to carry out usual activities. Medical intervention (including hospitalization or 
prolongation of hospitalization) required 
 
 


Version 1: October 8, 2021 
 
Relationship of Adverse Events 
It is the investigator’s responsibility to assess the relationship of an AE to the study procedure and study 
device.  
 
The following guidelines should be used in determining the relationship of an adverse evet to the study 
device, study procedure, or other causality:  
 
 
• 
NOT related: the event is due to extraneous causes 
• 
Possibly related: The event is unlikely associated, but another cause cannot be ruled out with 
certainty 
• 
Definitely related: the event is associated with a high degree of certainty 
• 
Unknown: the event cannot be defined by the categories listed above  
 
Reporting Adverse Events  
Investigators are required to report all AEs experienced by subjects from the time of enrollment until 
the subject completes the study or terminates early. All AEs, regardless of their relatedness to the study 
device must be reported. The investigator will evaluate the intensity of the event, severity of the event, 
and its relatedness to the study device or procedure. All AEs must be followed until resolution or until 
they become stable.  
 
Confidentiality  
The information from the study will be kept confidential and managed according to the requirement of 
HIPAA. Only the investigators of the study will have access to the data.  
 
Study Monitoring, Auditing, and Inspecting  
The investigator will permit study-related monitoring, audits and inspections by University of South 
Alabama IRB, and allow the sponsor and government regulatory bodies to study all related documents. 
 
Budget   
This is a non-funded project 
 
References 
Mauskar, M. M. (2021). Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen 
Sclerosus. Obstetrics & Gynecology, 137(6), 965-967. doi:10.1097/aog.0000000000004414 
 
Ferrara, F., Filippi, F., Messori, S., Iommi, M., Patrizi, A., D’Antuono, A., . . . Bardazzi, F. (2021). Fractional 
CO2 laser and vulvar lichen sclerosus: An alternative resource during maintenance therapy? A 
prospective study. Italian Journal of Dermatology and Venereology. doi:10.23736/s2784-8671.21.07066-
3 
 
Pagano, T., Conforti, A., Buonfantino, C., Schettini, F., Vallone, R., Gallo, A., . . . Sopracordevole, F. 
(2020). Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in 
women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: A 
prospective longitudinal study. Menopause, 27(4), 418-422. doi:10.1097/gme.0000000000001482