Fractionated CO2 Laser + Clobetasol for Vulvar Lichen Sclerosus

(VULVIE Trial)

Recruiting at 11 trial locations

Overseen By Melissa Gonzales

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Medstar Health Research Institute

Must be taking: Clobetasol

Must not be taking: Topical corticosteroids

Disqualifiers: Vaginal mesh, Genital infection, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

184 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using a special laser along with a strong anti-inflammatory cream can better treat women with vulvar lichen sclerosus compared to using the laser alone. The laser helps the skin heal by making tiny, controlled injuries, while the cream reduces swelling and itching. Researchers will compare improvements in symptoms and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use topical corticosteroids on the vulvovaginal area for 2 weeks before starting. If you have genital herpes, you should continue your suppression medication during the study.

What data supports the effectiveness of the treatment Fractionated CO2 Laser + Clobetasol for Vulvar Lichen Sclerosus?

Research shows that both clobetasol propionate ointment and fractionated CO2 laser therapy are effective in treating vulvar lichen sclerosus. Clobetasol, a strong steroid, helps reduce inflammation and symptoms, while the CO2 laser can improve skin texture and reduce scarring. ^{1 2 3 4 5}

Is the combination of Fractionated CO2 Laser and Clobetasol safe for treating vulvar lichen sclerosus?

Studies have shown that both fractionated CO2 laser and clobetasol propionate are generally safe for treating vulvar lichen sclerosus, with evaluations including quality of life and vulvar anatomy. No significant safety concerns were reported in the trials, suggesting these treatments are safe for human use. ^{1 2 3 5 6}

How does the Fractionated CO2 Laser + Clobetasol treatment differ from other treatments for vulvar lichen sclerosus?

The Fractionated CO2 Laser + Clobetasol treatment is unique because it combines a laser therapy with a topical steroid, offering a dual approach that may enhance effectiveness compared to using a steroid alone. The laser helps improve symptoms that are not fully controlled by steroids, potentially providing better long-term management of the condition. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for English or Spanish-speaking women aged 18 and older with diagnosed vulvar lichen sclerosus, who are willing to undergo CO2-laser therapy and use clobetasol ointment. It's not for those with vaginal mesh from pelvic surgery, active genital infections, prior LS treatments like laser or immunomodulators, undiagnosed vulvar lesions, cancer treatments, pregnancy plans or current pregnancy, recent corticosteroid use on the genitals, known allergies to clobetasol propionate, breastfeeding mothers or certain skin conditions.

Inclusion Criteria

I am willing and able to use a 0.05% clobetasol propionate treatment.

I speak English or Spanish.

I am a woman over 18 with confirmed or suspected Lynch syndrome.

Exclusion Criteria

I am allergic or cannot use clobetasol propionate 0.05%.

I have a skin condition that might affect treatment results.

I had surgery with vaginal mesh for pelvic organ prolapse, not including slings or sacrocolpopexy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FxCO2 laser therapy with either clobetasol propionate 0.05% ointment or placebo ointment

5 months

Multiple visits for laser treatments and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

Final study visit

Treatment Details

Interventions

• Clobetasol Propionate 0.05% Ointment
• Fractionated CO2-laser

Trial Overview The study tests if combining Fractionated CO2-laser treatment (FxCO2) with a traditional medication (clobetasol propionate ointment) is more effective than FxCO2-laser with placebo in treating vulvar lichen sclerosus. Success is measured by improvement in a quality of life questionnaire score. The study also compares changes in symptoms related to sexual function and self-image between the two groups.

Participant Groups

Group I: Clobetasol Group Active Control 2 Interventions

Clobetasol propionate 0.05% ointment is the active treatment arm that will be use in women with lichen sclerosus in the study per standard clinical recommendations. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).

Group II: Placebo Group Placebo Group 1 Intervention

Placebo ointment is the control treatment arm. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Society of Gynecologic Surgeons

Collaborator

Trials

1

Recruited

180+

Patty Brisben Foundation For Women's Sexual Health

Collaborator

Trials

7

Recruited

360+

Findings from Research

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]

References

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

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial. [2021]

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

Clobetasol propionate in the treatment of premenarchal vulvar lichen sclerosus. [2022]

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

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

4. Italy pubmed.ncbi.nlm.nih.gov

[Our experience in treating vulvar lichen sclerosus]. [2013]

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

Vulvar lichen sclerosus: a comparison of the short-term topical application of clobetasol dipropionate 0.05% versus mometasone furoate 0.1%. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial with fractional CO2 laser and Clobetasol in the treatment of Vulvar Lichen Sclerosus: a clinic study of feasibility. [2023]

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

Fractional CO2 laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus. [2022]