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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03926299

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 24, 2019

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.

  • Condition or Disease:Chronic Skin Disease
    Vulvar Lichen Sclerosus
  • Intervention/Treatment: Device: FotonaSmooth SP® Spectro laser device
    Drug: Clobetasol propionate 0.05% ointment
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated 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 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: June 2023
Arms and interventions
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.
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)
Outcome Measures
  • 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)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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

- 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

Contacts and Locations
Contacts

Contact: Volker Viereck, Prof. +41 52 723 7050 volker.viereck@stgag.ch

Locations

Switzerland, Thurgau
Cantonal Hospital Frauenfeld
Frauenfeld

Sponsors and Collaborators

Prof. Dr. Volker Viereck

Investigators

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

More Information
  • Responsible Party: Prof. Dr. Volker Viereck
  • ClinicalTrials.gov Identifier: NCT03926299 History of Changes
  • Other Study ID Numbers: Lichen sclerosus laser study
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 24, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Vulvar Lichen Sclerosus
    Skin Diseases
    Lichen Sclerosus et Atrophicus