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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fractional ablative laser treatment for Lichen Sclerosus lesion

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Clinique Medicale Uro-Gyneco de l'Abitibi
RECRUITING
Val-d'or
Contact Information
Primary
J Patel
clinicaltrials@sciton.com
6504939155
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 50
Treatments
Active_comparator: Treatment + PRP Arm
Active_comparator: Treatment only Arm
Related Therapeutic Areas
Sponsors
Leads: Sciton

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.