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Procedure

Laser Treatment for Lichen Sclerosus

N/A
Recruiting
Led By Josee Parent, MD
Research Sponsored by Sciton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-proven vulvar lichen sclerosus lesion
Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
Must not have
Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
History of uncontrolled malignant disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial is studying the use of a laser treatment for Lichen Sclerosus lesions."

Who is the study for?
This trial is for women over 18 with biopsy-proven vulvar lichen sclerosus, experiencing symptoms like dryness, itching, or pain. Participants must not be pregnant or nursing, have no allergies to local anesthesia, and cannot be on certain immunosuppressants or have a history of keloid formation.
What is being tested?
The study tests the effectiveness of a fractional ablative laser (2940 nm) in treating lesions caused by Lichen Sclerosus. Women will undergo scheduled treatments and follow-ups to see how well the laser improves their condition.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, redness, swelling, changes in skin coloration, scarring risk due to healing response variability among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of vulvar lichen sclerosus.
Select...
I do not have any infections in my vaginal area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any ongoing infections in my urinary or genital areas.
Select...
I have a history of cancer that was not controlled.
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I have a skin condition affecting my genital area or psoriasis.
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I am currently taking immunosuppressant medications.
Select...
I have a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Histological clearance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Treatment only ArmActive Control1 Intervention
Group II: Treatment + PRP ArmActive Control1 Intervention

Find a Location

Who is running the clinical trial?

ScitonLead Sponsor
19 Previous Clinical Trials
1,312 Total Patients Enrolled
Josee Parent, MDPrincipal InvestigatorClinique Medicale Uro-Gyneco de l'Abitibi
~33 spots leftby Dec 2025
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