Trials Sponsors Conditions Drugs Pricing

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)
+1 more other outcomes

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 deviceDevice

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% ointmentDrug

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)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of vulvar lichen sclerosus
Clinical LS score ≥ 4

You may not qualify if:

Sponsors & Collaborators

Prof. Dr. Volker Viereck
Otherlead

Study Sites (1)

Cantonal Hospital Frauenfeld

Frauenfeld, Thurgau, 8501, Switzerland

Related Publications (3)

Gamper M, Zivanovic I, Bischofberger H, Viereck V. One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial. Arch Gynecol Obstet. 2026 Jul 1. doi: 10.1007/s00404-026-08510-3. Online ahead of print.
PMID: 42384057DERIVED
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: 39998969DERIVED

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Laser TherapyClobetasolOintments

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation Techniques

Study Officials

Volker Viereck, Prof.
Department of Gynecology and Obstetrics
PRINCIPAL INVESTIGATOR

Enrollment

66 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 24, 2019

Study Start

July 15, 2019

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (4)

Study Arms (2)

Laser

Topical steroid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (4)

Study Arms (2)

Laser

Topical steroid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations