Laser Treatment for Lichen Sclerosus
ConditionLichen Sclerosus Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSciton
About this trial
Fractional ablative laser treatment for Lichen Sclerosus lesion
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female aged 18 years or older
Biopsy-proven vulvar lichen sclerosus lesion
Dryness
Itching
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Fractional 2940 nm Laser
DeviceFractional 2940 nm Laser
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Treatment + PRP ArmActive comparator 1 intervention
Group B: Treatment only ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Histological clearance
Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment
Time frame
16 weeks Source ClinicalTrials.gov