BridgeMD
New treatment option for Lichen Sclerosus Lesion
Official title Laser Treatment for Lichen Sclerosus
ClinicalTrials.gov ID: NCT06389071
What this study is testing
- What it's testing
- Fractional ablative laser treatment for Lichen Sclerosus lesion
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female aged 18 years or older
- Biopsy-proven vulvar lichen sclerosus lesion
- Experiencing one or more of the following symptoms of LS:
- Dryness
- Itching
You likely can't join if
- 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)
- people with genital skin disease, psoriasis due to risk of koeberizing
See the full eligibility criteria
- Female aged 18 years or older
- Biopsy-proven vulvar lichen sclerosus lesion
- Experiencing one or more of the following symptoms of LS:
- Dryness
- Itching
- Burning
- Bleeding
- Blistering
- Soreness
- Easily bruises
- Easily tears
- Ulcerated lesions
- 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
- 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)
- people with genital skin disease, psoriasis due to risk of koeberizing
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Val-d'Or, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Val-d'Or, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.