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NCT Number: NCT03926299

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

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.

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Key information

Conditions

Chronic Skin Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases Vulvar Lichen Sclerosus

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital Frauenfeld

Frauenfeld, Thurgau, 8501, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FotonaSmooth SP® Spectro laser device

Device

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

Other names: Laser therapy

clobetasol propionate 0.05% ointment

Drug

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)

Other names: Local steroid therapy

Primary outcomes

  1. Clinical Lichen sclerosus score (LS score)

    Time frame: 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 outcomes

  1. Vulvovaginal symptom questionnaire (VSQ)

    Time frame: 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.

  2. Symptom strength score

    Time frame: 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).

Other outcomes

  1. Vulvar punch biopsy

    Time frame: Baseline and at 6 months

    Histological changes

  2. Photo documentation of vulvar skin

    Time frame: At each visit through study completion, an average of 1 year

    Changes of visual appearance of vulvar skin

  3. Patient satisfaction

    Time frame: At each follow-up visit (6 months and 12 months)

    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

  4. Pain during treatment (for laser arm only): Visual analog scale (0-10)

    Time frame: At each laser treatment session (baseline, 1 month, 2 months, 4 months)

    Visual analog scale (0-10)

Sponsors and collaborators

Lead sponsor

Prof. Dr. Volker Viereck

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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