Laser treatment for lichen sclerosus lesions

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 clinical trial evaluates the effectiveness of fractional ablative laser treatment specifically for women suffering from vulvar lichen sclerosus lesions. Participants will undergo treatment using a 2940 nm laser, aimed at alleviating symptoms such as dryness, itching, and pain. The study will include women aged 18 and older with biopsy-proven lichen sclerosus and will monitor their response to the treatment over a series of scheduled follow-up visits. The trial emphasizes the importance of informed consent and the collection of clinical photographs and ultrasound images for assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female aged 18 years or older
* Biopsy-proven vulvar lichen sclerosus lesion
* Experiencing one or more of the following symptoms of LS:

  1. Dryness
  2. Itching
  3. Burning
  4. Bleeding
  5. Blistering
  6. Soreness
  7. Easily bruises
  8. Easily tears
  9. Ulcerated lesions
  10. Painful intercourse
* Negative urine pregnancy test if subject is of childbearing potential before enrollment
* Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
* Ability to understand and sign informed consent, questionnaires, and all investigation requirements
* Willing to consent to clinical photographs of the treatment area
* Willing to consent to ultrasound images of the treatment area
* Willing and able to logistically follow schedule of treatments and follow-up visits

Exclusion Criteria:

* Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data
* Is a nursing mother
* History of uncontrolled malignant disease
* Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
* Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
* Subjects with genital skin disease, psoriasis due to risk of koeberizing
* Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
* Known allergy or intolerance to local anesthesia
* Known history of connective tissue disease
* Known propensity for keloid formations
* Known medical condition that may affect wound healing
* Any reason that the investigator deems prohibits participation in the investigation

Where it's running

• Clinique Medicale Uro-Gyneco de l'Abitibi
  Val-d'Or, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Josee Parent, MD — Clinique Medicale Uro-Gyneco de l'Abitibi
• Study coordinator: J Patel
• Email: clinicaltrials@sciton.com
• Phone: 6504939155

Similar studies

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

• Genetic clues for lichen sclerosus in families

  Researchers will look for genetic variants linked to lichen sclerosus by sequencing the genomes of affected families to see which genes might contribute to the condition.

  Recruiting Medbase · Frauenfeld, Thurgau · NCT07720830

• 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

• 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

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.