Laser Therapy in Women With Lichenoid Disorders
Laser Therapy in Women With Lichenoid Disorders
Primary aim of the trial is to compare improvement of lichen symptoms according to a
 composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy
 vs. sham laser therapy at three months.
Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen
 planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both
 can cause vulvar itching, burning and pain and can lead to urinary and sexual dysfunction.
 Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an
 effective treatment option.

 Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women
 with lichenoid disorders.

 Design: Randomized double-blinded placebo- controlled clinical study

 Study Population: Women diagnosed with LD will be recruited from a specialized University
 outpatient clinic.

 Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2
 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus
 ongoing therapy

 Sample size Total 40 patients Primary study outcome: Visual analogue scale (VAS) composite
 score in regard to LD Secondary study outcomes: quality of life (QoL) (Skindex
 questionnaire); Treatment discomfort/ pain (VAS); Patient treatment satisfaction
 (Questionnaire to ask for treatment satifsaction: ZUF-8); Subjective improvement (Patient
 global impression of improvement- PGI-I), clinical LS score, histological appearance
Inclusion criteria

 -  women age >18 years

 -  diagnosed with LD (VLS or LP histologically proven)

 -  Clinical LS score ≥ 4 based on the score of Günthert et al. [1]

 -  Normal Pap-smear within 24 months

 -  negative clinical and microscopic evaluation of vaginal fluid

 -  Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea,
 genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal
 vaginal fluid

 -  Good German language skills

 -  written informed consent

 -  preceding local corticoid therapy of at least 12 weeks according to the current
 guideline for LD

 Exclusion criteria:

 -  women with contraindications for the use of laser on the skin

 -  pregnancy

 -  presence of vulvar pathology (other than lichen)

 -  any vulvar/ vaginal infection

 -  immunocompromised women

 -  swollen lymph nodes

 -  genital malignant disease

 -  allergy to topical anaesthesia

 -  connective tissue disease

 -  keloid formation

 -  Patients with a legal guardian

 -  Body Mass Index > 35 kg/m²

 -  History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)

 -  Coagulopathy

 -  patients using anticoagulants

 -  patients with renal, hepatic or pulmonary-cardiovascular failure

 -  patients who have undergone any kind of organ transplantation in the last three years.