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

March 19, 2026 updated by: Prof. Dr. Volker Viereck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Thurgau
      • Frauenfeld, Thurgau, Switzerland, 8501
        • Cantonal Hospital Frauenfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser
dual Fotona laser treatment (Nd:YAG and Er:YAG)
Device: FotonaSmooth 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.
Other Names:
  • Laser therapy
Active Comparator: Topical steroid
clobetasol propionate 0.05% cream
Drug: Clobetasol propionate 0.05% ointment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At each visit through study completion, an average of 1 year
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).
At each visit through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvar punch biopsy
Time Frame: Baseline and at 6 months
Histological changes
Baseline and at 6 months
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
At each visit through study completion, an average of 1 year
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
At each follow-up visit (6 months and 12 months)
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)
At each laser treatment session (baseline, 1 month, 2 months, 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Volker Viereck

Investigators

  • Principal Investigator: Volker Viereck, Prof., Department of Gynecology and Obstetrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lichen sclerosus laser study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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