Testing Fractional 2940 nm Laser for lichen sclerosus lesion
Official title: Laser Treatment for Lichen Sclerosus
Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
- 2 groups
- One site, in Val-d'Or
- Recruiting
Interventions
- Medical device
Fractional 2940 nm Laser
Fractional 2940 nm Laser
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Female aged 18 years or older
- +Biopsy-proven vulvar lichen sclerosus lesion
- +Experiencing one or more of the following symptoms of LS:
- +Blistering
- +Easily bruises
- +Easily tears
- +Ulcerated lesions
- +Painful intercourse
- +Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
- +Ability to understand and sign informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, 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-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits
- +Negative urine pregnancy test if subject is of childbearing potential before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
Exclusion
- −Known allergy or intolerance to local anesthesia
- −Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
- −History of uncontrolled malignant disease
- −Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
- −Subjects with genital skin disease, psoriasis due to risk of koeberizing
- −Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
- −Known history of connective tissue disease
- −Known propensity for keloid formations
- −Known medical condition that may affect wound healing
- −Any reason that the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → deems prohibits participation in the investigation
- −Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data
- −Is a nursing mother
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B, the comparison group, receive Fractional 2940 nm Laser.
Registry label: A: Treatment + PRP Arm · B: Treatment only Arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 16 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Histological clearance — measured over 16 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06389071 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Fractional 2940 nm LaserDevice
Fractional 2940 nm Laser
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 16 weeks.
The study as a whole is currently expected to finish around 2027-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Val-d'Or, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Fractional ablative laser treatment for Lichen Sclerosus lesion
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.