Comparing laser treatment to clobetasol for vulvar lichen sclerosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of laser maintenance therapy versus standard treatment with clobetasol propionate in patients with vulvar lichen sclerosus. The study aims to assess the impact of fractional CO2-Laser on skin quality and disease management compared to the traditional topical corticosteroid approach. Participants must have completed an initial 12-week treatment with clobetasol and will be randomly assigned to receive either laser treatment or continued clobetasol maintenance. The trial will also evaluate the duration of the laser's therapeutic effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pre- or postmenopausal
* 12 weeks of continuous topical clobetasol treatment completed.
* Written informed consent
* German speaking (Study information and IC available only in German)

Exclusion Criteria:

* Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use
* Contraindication for the use of topic clobetasol
* History of vulva laser
* Immune-suppression
* Pregnancy or planned pregnancy, breast feeding.
* Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.
* History of vulvar or pelvic radiation therapy
* Uncertain vulvar findings, which require a biopsy.
* Acute vulvitis, especially recurrent genital herpes
* History of vaginal mesh implantation within 6 months preceding this study
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
* Previous enrolment into the current investigation
* Enrolment of the PI, his/her family members, employees and other dependent persons

Where it's running

• Kantonsspital Winterthur
  Winterthur, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Gesine Meili, MD — Clinic of obstetrics and gynecology
• Study coordinator: Rebecca R Zachariah, MD
• Email: rebecca.zachariah@ksw.ch
• Phone: +41522663173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Delgocitinib Cream for Adult Lichen Sclerosus

  This study tests whether twice-daily delgocitinib cream works for adults with lichen sclerosus, first to find the best dose in women and then to evaluate it in both women and men.

  Recruiting at 33 sites Phase 3 LEO Pharma · Birmingham, Alabama and 32 other locations · NCT07335588

• Male lichen sclerosus: risk factors, treatments, and effects on quality of life

  This project will follow men with lichen sclerosus to see if routine treatments (like topical corticosteroids or circumcision) influence symptoms, disease progression, and quality of life over time.

  Recruiting Region Västerbotten · Umeå · NCT06984263

• Radiofrequency plus steroid cream versus steroid cream alone for vulvar lichen sclerosus

  This trial tests whether adding dynamic quadripolar radiofrequency to standard high‑potency steroid cream helps women of reproductive age with vulvar lichen sclerosus more than steroid cream alone.

  Recruiting Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Moscow · NCT07363733

• Methotrexate treatment for severe vulvar lichen sclerosus

  This trial will try methotrexate to reduce symptoms and prevent further scarring in women with severe vulvar lichen sclerosus who have not improved with high‑potency topical steroids.

  Recruiting Phase 2 Clinica Dermatologica Arbache ltda · São José dos Campos, São Paulo · NCT07352917

• Clobetasol ointment versus fractional CO2 laser for vulvar lichen sclerosus

  We are testing whether clobetasol ointment or fractional CO2 laser works better to reduce inflammation and symptoms in women with biopsy-confirmed vulvar lichen sclerosus who have not used topical corticosteroids.

  Recruiting Universidade Federal do Rio de Janeiro · Rio de Janeiro, Rio de Janeiro · NCT07240519

• Using StrataMGT to reduce symptoms of vulvar lichen sclerosus

  This study is testing if a new treatment called StrataMGT can help women with vulvar lichen sclerosus feel better and improve their quality of life.

  Recruiting at 3 sites Phase 1 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 2 other locations · NCT06662942

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.