Laser Treatment for Lichen Sclerosus

Overseen By J Patel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sciton

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Immunocompromised, Genital skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment for women with Lichen Sclerosus, a skin condition causing symptoms like itching, burning, and painful intercourse. Researchers aim to evaluate the effectiveness of a fractional 2940 nm laser (also known as Er:YAG Fractional 2940nm Laser or Pixel 2940), possibly combined with PRP (platelet-rich plasma), in improving these symptoms. Women with a confirmed diagnosis of vulvar Lichen Sclerosus who experience symptoms like dryness or blistering might be suitable candidates. Participants must attend all treatments and follow-up visits. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options for Lichen Sclerosus.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on immunosuppressants like mycophenolate, retinoids, azathioprine, or cyclosporin, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Fractional 2940 nm Laser is generally safe for treating conditions like Lichen Sclerosus. Studies have found that patients tolerate this laser treatment well, with few side effects. For instance, one study reported symptom improvement without major problems.

When combined with PRP (platelet-rich plasma), the laser treatment also appears safe. This combination has been tested for conditions like scars, with only minor side effects noted.

Overall, evidence suggests that both the laser alone and with PRP are safe options, with patients experiencing few issues during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the fractional 2940 nm laser for treating Lichen Sclerosus because it offers a unique approach compared to standard options like topical steroids and immune-modulating creams. Most existing treatments focus on reducing inflammation and managing symptoms over time. However, this laser treatment works by using precise laser energy to stimulate skin regeneration and improve tissue quality, potentially offering a more direct method to address the underlying skin changes caused by the condition. Additionally, one arm of the trial combines the laser with Platelet-Rich Plasma (PRP), which could enhance healing and regeneration, making it a promising alternative for more rapid and effective relief.

What evidence suggests that this trial's treatments could be effective for Lichen Sclerosus?

Research has shown that the fractional 2940 nm Er:YAG laser can help treat lichen sclerosus. In some studies, patients experienced a 50-100% improvement in symptoms like itching and skin changes after three months. This trial will compare two treatment approaches: one group will receive the laser treatment alone, while another group will receive the laser treatment combined with platelet-rich plasma (PRP). PRP uses components of the patient's own blood to aid healing. Some evidence suggests that combining the laser with PRP might enhance results, as it has shown better improvement in other skin conditions compared to using the laser alone. ^{1 2 3 4 6}

Who Is on the Research Team?

Josee Parent, MD

Principal Investigator

Clinique Medicale Uro-Gyneco de l'Abitibi

Are You a Good Fit for This Trial?

This trial is for women over 18 with biopsy-proven vulvar lichen sclerosus, experiencing symptoms like dryness, itching, or pain. Participants must not be pregnant or nursing, have no allergies to local anesthesia, and cannot be on certain immunosuppressants or have a history of keloid formation.

Inclusion Criteria

Willing and able to logistically follow schedule of treatments and follow-up visits

I am a woman aged 18 or older.

Negative urine pregnancy test if subject is of childbearing potential before enrollment

Exclusion Criteria

Known allergy or intolerance to local anesthesia

Is a nursing mother

I have a history of cancer that was not controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional ablative laser treatment for Lichen Sclerosus lesion

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractional 2940 nm Laser

Trial Overview The study tests the effectiveness of a fractional ablative laser (2940 nm) in treating lesions caused by Lichen Sclerosus. Women will undergo scheduled treatments and follow-ups to see how well the laser improves their condition.

How Is the Trial Designed?

Group I: Treatment only Arm Active Control 1 Intervention

Group II: Treatment + PRP Arm Active Control 1 Intervention

Fractional 2940 nm Laser is already approved in European Union, United States for the following indications:

Approved in European Union as Pixel 2940 for:

• Skin resurfacing
• Lichen sclerosus

Approved in United States as Pixel 2940 for:

• Fractional ablative laser skin resurfacing
• Lichen sclerosus

Who Is Running the Clinical Trial?

Sciton

Lead Sponsor

Trials

20

Recruited

1,400+

Published Research Related to This Trial

A 69-year-old man with penile lichen sclerosus underwent five treatments with a fractional micro-ablative CO2 laser, showing significant symptom improvement after the first session.

Complete clinical remission was achieved 14 weeks after the final treatment, suggesting that this laser therapy could be an effective alternative to traditional treatments like topical steroids or circumcision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Micro-ablative CO2 Laser as Therapy in Penile Lichen Sclerosus. Campolmi, P., Cannarozzo, G., Bennardo, L., et al.[2022]

In a study of 28 women with vulvar lichen sclerosus, treatment with Er:YAG lasers resulted in significant reductions in symptoms such as itching and pain, as well as improvements in skin lesions after three sessions.

The Er:YAG laser treatment was found to be safe and well-tolerated, effectively improving the quality of life for patients suffering from vulvar lichen sclerosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Er:YAG laser in the treatment of vulvar lichen sclerosus. Gómez-Frieiro, M., Laynez-Herrero, E.[2022]

A study involving 40 women with vulvar lichen sclerosus found that fractionated CO2 laser therapy did not significantly improve histopathology scores compared to a sham treatment, indicating it is not an effective standalone treatment for this condition.

The trial was well-designed with a double-blind, randomized, sham-controlled approach, but the results showed no statistically significant difference in treatment outcomes, suggesting that alternative therapies may be needed for managing vulvar lichen sclerosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Mitchell, L., Goldstein, AT., Heller, D., et al.[2023]

In a randomized controlled trial involving 40 female patients with vulvar lichen sclerosus, neodymium: yttrium aluminum garnet laser treatment showed significantly greater improvement in symptoms and patient satisfaction compared to topical corticosteroids, with effects lasting up to 6 months.

The laser treatment was well-tolerated, causing minimal discomfort (average 1.5 out of 10) and no adverse effects, making it a promising alternative for patients who do not respond to corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial. Bizjak Ogrinc, U., Senčar, S., Luzar, B., et al.[2020]

This study protocol outlines a clinical trial involving 66 patients to compare the efficacy of a novel dual Nd:YAG/Er:YAG laser therapy against the standard lifelong topical steroid treatment for vulvar lichen sclerosus, with follow-ups planned at 6, 12, and 24 months.

The primary outcome will assess the effectiveness of the laser treatment at the 6-month mark, potentially providing a new non-invasive alternative for managing this chronic inflammatory skin disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial. Viereck, V., Gamper, M., Regauer, S., et al.[2023]

In a study of 40 women with recalcitrant lichen sclerosus, 72.5% reported significant improvement in symptoms after treatment with a fractionated CO2 laser, indicating its efficacy for this condition.

The treatment led to a notable reduction in vaginal pain, itching, and other symptoms, as well as a decrease in the need for corticosteroids, suggesting it may be a valuable alternative for patients not responding to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated CO2 Laser as Therapy in Recalcitrant Lichen Sclerosus. Balchander, D., Nyirjesy, P.[2021]

In a study involving 10 patients with penile lichen sclerosus, treatment with fractional CO2 laser therapy resulted in a fast clinical recovery and improved sexual function, enhancing overall quality of life.

The positive outcomes were assessed through various questionnaires over multiple visits, indicating that this laser treatment can be beneficial during the non-active phase of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional CO2 laser therapy of lichen sclerosus in males: a new therapeutic opportunity? Ferrara, F., Messori, S., Abbenante, D., et al.[2022]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/94/NCT04134494/Prot_SAP_000.pdf

Effectiveness of Ablative Fractional 2940 nm Laser ... The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10293446/

Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar ... Presentation of a novel non-invasive double laser therapy to treat vulvar lichen sclerosus. In a randomized controlled trial with a follow-up of ...

3. researchgate.net researchgate.net/publication/321785525_Vulvar_lichen_sclerosus_description_of_5_cases_successfully_treated_with_the_2940nm_Erbium-YAG_laser

(PDF) Vulvar lichen sclerosus: description of 5 cases ... none have used the fractional 2,940 Er:YAG fractional laser. The purpose of this study was to evaluate the efficacy of. the 2,940 Er:YAG ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.17737

Nd:YAG/Er:YAG dual laser compared with topical steroid to ... Non-ablative dual Nd:YAG/Er:YAG laser therapy was safe and significantly improved clinical outcome and subjective symptoms at the 6-month follow up.

5. coyleinstitute.com coyleinstitute.com/wp-content/uploads/2018/06/Vulvar-lichen-sclerosus-poster-1.pdf

The Safety and Efficacy of Ablative Fractional Er:YAG Laser ... Three month biopsy data showed 50-100% improvement over baseline in VLS symptoms. Aim. To evaluate the safety and efficacy of ablative fractional 2940nm. Er:YAG ...

6. withpower.com withpower.com/trial/phase-lichen-sclerosus-et-atrophicus-2-2024-8a0f1

Laser Treatment for Lichen Sclerosus This N/A medical study run by Sciton is evaluating whether Fractional 2940 nm Laser will have tolerable side effects & efficacy for patients with Lichen ...