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

Trial Summary

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.

What data supports the effectiveness of the laser treatment for lichen sclerosus?

Research shows that the Er:YAG laser can improve symptoms of vulvar lichen sclerosus, and similar positive results have been seen with fractional CO2 lasers for both vulvar and penile lichen sclerosus. These studies suggest that laser treatments can be effective in managing this condition. ^{1 2 3 4 5}

Is laser treatment safe for humans?

Research on various types of lasers, including Er:YAG and CO2 lasers, suggests they are generally safe for treating lichen sclerosus, with studies focusing on both safety and effectiveness. ^{1 2 3 5 6}

How is the Fractional 2940 nm Laser treatment different from other treatments for lichen sclerosus?

The Fractional 2940 nm Laser treatment is unique because it uses a specific type of laser (Er:YAG) to target and improve symptoms of lichen sclerosus, offering a non-invasive alternative to traditional treatments like topical steroids or surgery. This laser treatment works by creating tiny, controlled injuries in the skin, which can stimulate healing and improve skin texture. ^{1 2 3 4 7}

What is the purpose of this trial?

Fractional ablative laser treatment for Lichen Sclerosus lesion

Research Team

Josee Parent, MD

Principal Investigator

Clinique Medicale Uro-Gyneco de l'Abitibi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Treatment + PRP Arm Active Control 1 Intervention

Group II: Treatment only 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+

Findings from Research

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Er:YAG laser in the treatment of vulvar lichen sclerosus. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. [2023]

3. Iran pubmed.ncbi.nlm.nih.gov

Fractional Micro-ablative CO2 Laser as Therapy in Penile Lichen Sclerosus. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Fractionated CO2 Laser as Therapy in Recalcitrant Lichen Sclerosus. [2021]

5. Germany 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Fractional CO2 laser therapy of lichen sclerosus in males: a new therapeutic opportunity? [2022]