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

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ClinicalTrials.gov Identifier: NCT03926299
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : February 3, 2022
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld

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.

Condition or disease Intervention/treatment Phase
Chronic Skin Disease Vulvar Lichen Sclerosus Device: FotonaSmooth SP® Spectro laser device Drug: Clobetasol propionate 0.05% ointment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, active-controlled
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

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 Name: 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 Name: Local steroid therapy

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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).

Other Outcome Measures:
  1. Vulvar punch biopsy [ Time Frame: Baseline and at 6 months ]
    Histological changes

  2. 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

  3. 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

  4. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926299

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Cantonal Hospital Frauenfeld
Frauenfeld, Thurgau, Switzerland, 8501
Sponsors and Collaborators
Prof. Dr. Volker Viereck
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Principal Investigator: Volker Viereck, Prof. Department of Gynecology and Obstetrics
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Responsible Party: Prof. Dr. Volker Viereck, Head of Urogynecology, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT03926299    
Other Study ID Numbers: Lichen sclerosus laser study
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Skin Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Vulvar Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs