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

Primary Purpose

Chronic Skin Disease, Vulvar Lichen Sclerosus

Status

Active

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

FotonaSmooth SP® Spectro laser device

Clobetasol propionate 0.05% ointment

About this trial

This is an interventional treatment trial for Chronic Skin Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cantonal Hospital Frauenfeld

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser

Topical steroid

Arm Description

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

clobetasol propionate 0.05% cream

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Vulvovaginal symptom questionnaire (VSQ)

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

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).

Full Information

NCT ID

NCT03926299

First Posted

April 18, 2019

Last Updated

August 30, 2023

Sponsor

Prof. Dr. Volker Viereck

1. Study Identification

Unique Protocol Identification Number

NCT03926299

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dr. Volker Viereck

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Skin Disease, Vulvar Lichen Sclerosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized, active-controlled

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser

Arm Type

Experimental

Arm Description

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

Arm Title

Topical steroid

Arm Type

Active Comparator

Arm Description

clobetasol propionate 0.05% cream

Intervention Type

Device

Intervention Name(s)

FotonaSmooth SP® Spectro laser device

Other Intervention Name(s)

Laser therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clobetasol propionate 0.05% ointment

Other Intervention Name(s)

Local steroid therapy

Intervention Description

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)

Primary Outcome Measure Information:

Title

Clinical Lichen sclerosus score (LS score)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Vulvovaginal symptom questionnaire (VSQ)

Description

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.

Time Frame

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

Title

Symptom strength score

Description

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).

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Vulvar punch biopsy

Description

Histological changes

Time Frame

Baseline and at 6 months

Title

Photo documentation of vulvar skin

Description

Changes of visual appearance of vulvar skin

Time Frame

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

Title

Patient satisfaction

Description

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

Time Frame

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

Title

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

Description

Visual analog scale (0-10)

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Volker Viereck, Prof.

Organizational Affiliation

Department of Gynecology and Obstetrics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cantonal Hospital Frauenfeld

City

Frauenfeld

State/Province

Thurgau

ZIP/Postal Code

8501

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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