Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus

Vulvar Lichen Sclerosus Clinical Trial

Official title:

Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03926299
• Other study ID #: Lichen sclerosus laser study
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Cantonal Hospital, Frauenfeld
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.

Description:

Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of vulvar lichen sclerosus
• Clinical LS score = 4

Exclusion criteria:

• Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
• < 3 months since start of vaginal estrogen treatment
• Malignant disease as the cause of the vulval symptoms
• BMI > 35 kg/m²
• Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
• Presence of contraindications for the laser treatment or topical steroid treatment

Related Conditions & MeSH terms

• Chronic Skin Disease
• Lichen Sclerosus et Atrophicus
• Skin Diseases
• Vulvar Lichen Sclerosus

Intervention

Device:
• FotonaSmooth SP® Spectro laser device
dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.

Drug:
• Clobetasol propionate 0.05% ointment
6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Frauenfeld	Frauenfeld	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Volker Viereck

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vulvar punch biopsy	Histological changes	Baseline and at 6 months
Other	Photo documentation of vulvar skin	Changes of visual appearance of vulvar skin	At each visit through study completion, an average of 1 year
Other	Patient satisfaction	Satisfaction of the treatment. Levels: 3 = very much better, 2 = much better, 1 = a little better, 0 = no change, -1 = a little worse, -2 = much worse, -3 = very much worse	At each follow-up visit (6 months and 12 months)
Other	Pain during treatment (for laser arm only): Visual analog scale (0-10)	Visual analog scale (0-10)	At each laser treatment session (baseline, 1 month, 2 months, 4 months)
Primary	Clinical Lichen sclerosus score (LS score)	Reduction (i.e. improvement) of physician administered clinical LS score (Sum score of 6 items on a scale from 0-2 (0=no, 1=weak, 2=pronounced): erosions, hyperkeratosis, fissures, agglutination, stenosis, atrophy). Possible sum score ranges from 0 (normal) to 12 (maximum symptoms present).	6 months
Secondary	Vulvovaginal symptom questionnaire (VSQ)	21 binary questions (0=no, 1=yes) about symptoms, emotional impact, impact on quality of life, impact on sexual activity. Total possible sum score is 21.	At each visit through study completion, an average of 1 year
Secondary	Symptom strength score	Visual analog scale (0-10) of LS symptoms itching, burning, vulvar pain, dyspareunia. Total sum score ranges from 0 (no symptoms) to 40 (maximal symptoms).	At each visit through study completion, an average of 1 year