Laser Treatment for Lichen Sclerosus

Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion

Fractional ablative laser treatment for Lichen Sclerosus lesion

Study Overview

• Status: Recruiting
• Conditions: Lichen Sclerosus Lesion
• Intervention / Treatment: Device: Fractional 2940 nm Laser

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: J Patel; Phone Number: 6504939155; Email: clinicaltrials@sciton.com

Study Locations

• Canada
  • Quebec
    • Val-d'Or, Quebec, Canada, J9P1W1
      • Recruiting
      • Clinique Medicale Uro-Gyneco de l'Abitibi
      • Contact: Josee Parent, MD; Phone Number: 819-825-3800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment + PRP Arm	Device: Fractional 2940 nm Laser; Fractional 2940 nm Laser
Active Comparator: Treatment only Arm	Device: Fractional 2940 nm Laser; Fractional 2940 nm Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological clearance	Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment	16 weeks

Collaborators and Investigators

• Sponsor: Sciton
• Investigators: Principal Investigator: Josee Parent, MD, Clinique Medicale Uro-Gyneco de l'Abitibi

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Sclerosus et Atrophicus; Equipment and Supplies; Optical Devices; Radiation Equipment and Supplies; Lasers
• Other Study ID Numbers: PLS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No