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

Not Applicable

Active, not recruiting

• Conditions: Chronic Skin Disease; Vulvar Lichen Sclerosus
• Interventions: Device: FotonaSmooth SP® Spectro laser device; Drug: Clobetasol propionate 0.05% ointment

• Registration Number: NCT03926299
• Lead Sponsor: Prof. Dr. Volker Viereck

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.

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 Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2019-07-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	FotonaSmooth SP® Spectro laser device	dual Fotona laser treatment (Nd:YAG and Er:YAG)
Topical steroid	Clobetasol propionate 0.05% ointment	clobetasol propionate 0.05% cream

Primary Outcome Measures

Name	Time	Method
Clinical Lichen sclerosus score (LS score)	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 Outcome Measures

Name	Time	Method
Vulvovaginal symptom questionnaire (VSQ)	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.
Symptom strength score	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).

Trial Locations

Locations (1)

Cantonal Hospital Frauenfeld; 🇨🇭 Frauenfeld, Thurgau, Switzerland