Fractionated CO2 Laser + Clobetasol for Vulvar Lichen Sclerosus

(VULVIE Trial)

No longer recruiting at 12 trial locations

Overseen By Silpa Nekkanti

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a specialized laser treatment with a topical ointment (clobetasol, a corticosteroid) can better alleviate symptoms of vulvar lichen sclerosus—a chronic skin condition causing itchiness and discomfort—compared to the laser treatment alone. Participants will receive either the combination treatment or the laser with a placebo ointment to determine which approach offers more relief. Women diagnosed with vulvar lichen sclerosus and planning to undergo laser therapy might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

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 is the safety track record for the Fractionated CO2 Laser and Clobetasol Propionate 0.05% Ointment treatments?

Research has shown that fractionated CO2 laser treatment is generally safe for people with vulvar lichen sclerosus. Studies have found that this laser treatment improves symptoms and is well-tolerated, with patients typically not experiencing serious side effects.

The FDA has approved clobetasol propionate, a strong steroid ointment, for treating skin conditions like lichen sclerosus. This approval indicates its safety when used as directed. While mild side effects such as skin thinning or irritation can occur, they are usually manageable.

Both treatments have undergone extensive study and use, with no major safety concerns identified in previous research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about combining fractionated CO2 laser therapy with clobetasol for vulvar lichen sclerosus because it offers a novel approach by pairing two different treatment methods. Most treatments for this condition, such as topical corticosteroids like clobetasol alone, primarily aim to reduce inflammation and symptoms. However, the fractionated CO2 laser works differently by using laser energy to stimulate collagen production and tissue remodeling, potentially improving skin texture and elasticity. This dual approach not only targets inflammation but also enhances tissue healing, which could lead to better and longer-lasting results than existing treatments.

What evidence suggests that this trial's treatments could be effective for vulvar lichen sclerosus?

Research has shown that fractional CO2 laser treatment can alleviate symptoms of lichen sclerosus, such as itching and burning. In one study, many patients reported high satisfaction with the results. Another study found significant improvement in vaginal health with this treatment. In this trial, some participants will receive Clobetasol propionate 0.05% ointment, a common and effective treatment for reducing symptoms like itching and skin thickening. Combining the laser with clobetasol may enhance these benefits, potentially leading to better overall symptom relief. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 am choosing to have CO2-laser therapy.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34878932/

Effects of Fractional CO2 Laser Treatment on Patients ... Vaginal dryness, itching, and burning were significantly improved as well. Most patients declared to be very satisfied with the results of the treatment. A ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70098

Retrospective Study on CO2 Laser for Second‐Line Treatment ... VHI showed significant improvement after completion of treatment compared to baseline (p < 0.001). There was clear improvement, compared to ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2025.2507958

Full article: The comparison of fractional CO2 laser and ... At the 6-month follow-up, the total effective rates for FxCO2 decreased to 85.29% (29/34), while FUS remained at 88.57% (31/35) (p > 0.05). Recurrence rates ...

4. mdpi.com mdpi.com/2075-1729/14/12/1678

Efficacy of Fractional CO2 Laser Therapy in Improving ... This prospective observational study investigated the short-term efficacy and safety of fractional CO 2 laser therapy in 75 women with refractory LS.

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02573883

Study Details | NCT02573883 | Clobetasol Propionate ... This study is being done to compare the effects, good and bad, of fractionated CO2 laser treatment and clobetasol propionate .05% ointment on vulvar lichen ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33957642/

Clobetasol Compared With Fractionated Carbon Dioxide ... Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate.