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

NCT03926299 | Completed

• 1 other identifier: Lichen sclerosus laser study
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Skin Disease; Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vulvovaginal symptom questionnaire (VSQ)

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

• Symptom strength score

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

Other Outcomes (4)

• Vulvar punch biopsy

  Baseline and at 6 months

• Photo documentation of vulvar skin

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

• Patient satisfaction

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

Study Arms (2)

Laser

EXPERIMENTAL

dual Fotona laser treatment (Nd:YAG and Er:YAG)

Device: FotonaSmooth SP® Spectro laser device

Topical steroid

ACTIVE COMPARATOR

clobetasol propionate 0.05% cream

Drug: Clobetasol propionate 0.05% ointment

Interventions

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.

Also known as: Laser therapy

Laser

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)

Also known as: Local steroid therapy

Topical steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Volker Viereck: lead

Study Sites (1)

Cantonal Hospital Frauenfeld

Frauenfeld, Thurgau, 8501, Switzerland

Location

Related Publications (2)

• Zivanovic I, Gamper M, Fesslmeier D, Bischofberger H, Viereck V. A randomized controlled trial to evaluate a novel dual laser therapy for vulvar lichen sclerosus: exploratory study assessing the impact of menopausal status. Menopause. 2025 Mar 1;32(3):228-233. doi: 10.1097/GME.0000000000002478. Epub 2025 Feb 21.

  PMID: 39998969 DERIVED

• Viereck V, Gamper M, Regauer S, Walser C, Zivanovic I. Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial. Arch Gynecol Obstet. 2023 Aug;308(2):643-649. doi: 10.1007/s00404-023-07055-z. Epub 2023 May 5.

  PMID: 37145134 DERIVED

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Laser Therapy; Clobetasol; Ointments

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Volker Viereck, Prof.

  Department of Gynecology and Obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Urogynecology

Model Details: randomized, active-controlled

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 24, 2019
• Study Start: July 15, 2019
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)