Clinical trial NCT03926299: Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Skin Disease
Vulvar Lichen Sclerosus
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, active-controlled
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Lichen sclerosus score (LS score)
timeFrame: 6 months
Secondary outcomes:
measure: Vulvovaginal symptom questionnaire (VSQ)
timeFrame: At each visit through study completion, an average of 1 year
measure: Symptom strength score
timeFrame: At each visit through study completion, an average of 1 year
Other outcomes:
measure: Vulvar punch biopsy
timeFrame: Baseline and at 6 months
measure: Photo documentation of vulvar skin
timeFrame: At each visit through study completion, an average of 1 year
measure: Patient satisfaction
timeFrame: At each follow-up visit (6 months and 12 months)
measure: Pain during treatment (for laser arm only): Visual analog scale (0-10)
timeFrame: At each laser treatment session (baseline, 1 month, 2 months, 4 months)
Locations:
city: Frauenfeld
country: Switzerland
facility: Cantonal Hospital Frauenfeld
state: Thurgau
Study officials:
affiliation: Department of Gynecology and Obstetrics
name: Volker Viereck, Prof.
role: PRINCIPAL_INVESTIGATOR
References: