Lichen Sclerosus LesionNCT06389071
Laser Treatment for Lichen Sclerosus
A study testing Fractional 2940 nm Laser in people with Lichen Sclerosus Lesion, run by Sciton at 1 site in Canada.
Trial summary
Fractional ablative laser treatment for Lichen Sclerosus lesion Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lichen Sclerosus Lesion
- What is being tested?
- Fractional 2940 nm Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
- Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
- Subjects with genital skin disease, psoriasis due to risk of koeberizing
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- Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
- Known allergy or intolerance to local anesthesia
- Known history of connective tissue disease
- Known propensity for keloid formations
- Known medical condition that may affect wound healing
- Any reason that the investigator deems prohibits participation in the investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec, J9P1W1
Josee Parent, MD, 819-825-3800
About this study
Official title: Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
Fractional ablative laser treatment for Lichen Sclerosus lesion
- Conditions
- Lichen Sclerosus Lesion
- Being tested
- Fractional 2940 nm Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional 2940 nm LaserDevice
Fractional 2940 nm Laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment + PRP Arm | Active comparator | Not described Receives: Device: Fractional 2940 nm Laser |
| Treatment only Arm | Active comparator | Not described Receives: Device: Fractional 2940 nm Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological clearance
Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Mar 2024
- Primary completion20 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Sclerosus LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josee Parent, MD, Principal investigator, Clinique Medicale Uro-Gyneco de l'Abitibi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389071
- Sponsor's protocol ID
- PLS001
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
- ClinicalTrials.gov ID
- NCT06389071
- Acronym / sponsor ID
- PLS001
- Conditions
- Lichen Sclerosus Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fractional ablative laser treatment for Lichen Sclerosus lesion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment + PRP Arm | Active comparator | Device: Fractional 2940 nm Laser |
| Treatment only Arm | Active comparator | Device: Fractional 2940 nm Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female aged 18 years or older
- Biopsy-proven vulvar lichen sclerosus lesion
- Experiencing one or more of the following symptoms of LS:
- Negative urine pregnancy test if subject is of childbearing potential before enrollment
- Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
Key exclusion criteria (12 listed)
- 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)
- Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional 2940 nm LaserFractional 2940 nm Laser | Device | Treatment + PRP Arm, Treatment only Arm |
Primary outcome
Histological clearance
Time frame: 16 weeks
Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josee Parent, MD principal investigator
Clinique Medicale Uro-Gyneco de l'Abitibi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional 2940 nm Laser in people with Lichen Sclerosus Lesion, run by Sciton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J Patel (6504939155, clinicaltrials@sciton.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological clearance (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.