ClinicalTrials.gg
RecruitingNCT06389071Updated Apr 23, 2026

Laser Treatment for Lichen Sclerosus

An interventional study of Fractional 2940 nm Laser in Lichen Sclerosus Lesion, sponsored by Sciton. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Sciton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Fractional ablative laser treatment for Lichen Sclerosus lesion

02

Conditions studied

  • Lichen Sclerosus Lesion
03

In context

Lichen Sclerosus et Atrophicus

30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.

This study's planned enrollment of 50 is above the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.

Browse Lichen Sclerosus et Atrophicus studies →

Lead sponsor

Sciton is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female aged 18 years or older
  • -proven vulvar lichen sclerosus lesion
  • Experiencing one or more of the following symptoms of LS:

    1. Dryness
    2. Itching
    3. Burning
    4. Bleeding
    5. Blistering
    6. Soreness
    7. Easily bruises
    8. Easily tears
    9. Ulcerated lesions
    10. Painful intercourse
  • Negative urine pregnancy test if subject is of before enrollment
  • Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
  • Ability to understand and sign , 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
  • Subjects with genital skin disease, psoriasis due to risk of koeberizing
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Treatment + PRP Arm

    Device: Fractional 2940 nm Laser

  • Active comparator
    Treatment only Arm

    Device: Fractional 2940 nm Laser

Interventions

  • DeviceFractional 2940 nm Laser

    Fractional 2940 nm Laser

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Clinique Medicale Uro-Gyneco de l'Abitibi
    Val-d'Or, Quebec J9P1W1, Canada
    Recruiting
    • Josee Parent, MD · Contact819-825-3800
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Jul 2027, 40 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 29, 2024
StartActual
Mar 1, 2024
Primary completionEst.
Jul 20, 2027
CompletionEst.
Dec 30, 2027
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06389071
Lead sponsor
Sciton
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
Mar 1, 2024
Primary completion
Jul 20, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

J Patel
Contact
clinicaltrials@sciton.com
6504939155
Josee Parent, MD
principal investigator · Clinique Medicale Uro-Gyneco de l'Abitibi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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