Laser Treatment for Lichen Sclerosus
Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
1 other identifier
interventional
50
1 country
1
Brief Summary
Fractional ablative laser treatment for Lichen Sclerosus lesion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 24, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
April 23, 2026
April 1, 2026
3.4 years
April 24, 2024
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Histological clearance
Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment
16 weeks
Study Arms (2)
Treatment + PRP Arm
ACTIVE COMPARATORTreatment only Arm
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify 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
- 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
- +4 more criteria
You may not qualify 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scitonlead
Study Sites (1)
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec, J9P1W1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josee Parent, MD
Clinique Medicale Uro-Gyneco de l'Abitibi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2024
First Posted
April 29, 2024
Study Start
March 1, 2024
Primary Completion (Estimated)
July 20, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04