Chronic Skin Disease, Vulvar Lichen Sclerosus
Conditions
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.
Interventions
DEVICEFotonaSmooth 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.
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)
Sponsors
Prof. Dr. Volker Viereck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, active-controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Lichen sclerosus score (LS score) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vulvovaginal symptom questionnaire (VSQ) | At each visit through study completion, an average of 1 year | 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. |
| Symptom strength score | At each visit through study completion, an average of 1 year | 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). |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORVolker Viereck, Prof.
Department of Gynecology and Obstetrics
Outcome results
None listed