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Laser Therapy

Ablative Fractional 2940 nm Laser for Vulvar Lichen Sclerosus

N/A
Waitlist Available
Led By Roger Lefevre, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 9 month follow up visit
Awards & highlights

Study Summary

This trial will assess whether the fractional 2940 nm laser is an effective treatment for vulvar lichen sclerosus, a chronic inflammatory skin condition.

Eligible Conditions
  • Vulvar Lichen Sclerosus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 9 month follow up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 9 month follow up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in histology and depth of disease from baseline to three months after the last laser treatment
Secondary outcome measures
Change in symptom severity using the Patient Global Impression Scale of Severity (PGIS)
Candidiasis, Vulvovaginal
Change in symptoms using the Patient Global Impression Scale of Change (PGIC)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,258 Total Patients Enrolled
ScitonIndustry Sponsor
18 Previous Clinical Trials
1,297 Total Patients Enrolled
Roger Lefevre, MDPrincipal Investigator - Beth Israel Deaconess Medical Center
Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Medical Center
SuNew York At StoNew York Brook Hlth Sci Center (Medical School)
Lehigh Valley Hospital (Residency)
1 Previous Clinical Trials
64 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Pennsylvania
Rhode Island
How old are they?
18 - 65
What site did they apply to?
BIDMC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Laser Treatment for Vulvar Lichen Sclerosus
Roger Lefevre 2020. "Laser Treatment for Vulvar Lichen Sclerosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04134494.
~3 spots leftby Apr 2025
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