Clobetasol Proprionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus (CuRLS)
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ClinicalTrials.gov Identifier: NCT02573883 |
Recruitment Status :
Completed
First Posted : October 12, 2015
Last Update Posted : December 17, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vulvar Lichen Sclerosus | Device: Fractionated Carbon Dioxide Laser Drug: Clobetasol Propionate 0.05% ointment | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of Clobetasol Proprionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus (CuRLS) |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | September 2019 |
Actual Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Prior Clobetasol Exposure
Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate
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Device: Fractionated Carbon Dioxide Laser
Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.
Other Names:
Drug: Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.
Other Name: Temovate Propionate 0.05% ointment |
Active Comparator: No Prior Clobetasol Exposure
Patients with biopsy proven lichen sclerosus never previously treated with clobetasol propionate.
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Device: Fractionated Carbon Dioxide Laser
Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.
Other Names:
Drug: Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.
Other Name: Temovate Propionate 0.05% ointment |
- SkinDEX-29 Score [ Time Frame: Change from baseline score to score at six months ]Validated subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus, described as a total numeric score
- Number of patients with adverse outcomes [ Time Frame: One year from treatment ]Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
- Number of patients with adverse outcomes [ Time Frame: 6 months from treatment ]Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
- Number of patients with adverse outcomes [ Time Frame: 12 weeks from treatment ]Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
- Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [ Time Frame: One year from treatment ]Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus
- Health Related Quality of Life (HRQOL) Score [ Time Frame: Six months from treatment ]Patient global impression of improvement and satisfaction total score on visual analog scale
- Health Related Quality of Life (HRQOL) Score [ Time Frame: 1 year from treatment ]Patient global impression of improvement and satisfaction total score on visual analog scale
- Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to 6 months after treatment ]Provider scored objective appearance of vulvar Lichen Sclerosus total
- Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to one year after treatment ]Provider scored objective appearance of vulvar Lichen Sclerosus total
- Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to six month after treatment ]Visual objective comparison of Lichen Sclerosus
- Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to one year after treatment ]Visual objective comparison of Lichen Sclerosus
- Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Change from baseline to 6 months after treatment ]Objective provider scale of visual appearance of Lichen Sclerosus total score
- Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Change from baseline to one year after treatment ]Objective provider scale of visual appearance of Lichen Sclerosus total score
- SkinDEX-29 Score [ Time Frame: Change from baseline score to score at one year ]Validated subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus, described as a total numeric score

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Biopsy proven symptomatic vulvar lichen sclerosus
- Ability to understand the study, accept randomization and logistically follow-up with scheduled visits
- English Speaking
Exclusion Criteria:
- Known vulvar malignancy
- Pregnancy or planning pregnancy or less than 3 months postpartum
- Premenopausal
- Current or prior diagnosis of any gynecologic malignancy
- Previous pelvic radiation therapy
- Allergy to topical steroid
- Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial vaginosis, trichomoniasis or other infection)
- Pelvic organ prolapse > than Stage 2
- Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus, pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of enrollment
- History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
- IUD (Intrauterine Device)
- Skindex-29 overall score <21, below mildly impaired health related quality of life threshold

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573883
United States, District of Columbia | |
Medstar Washington Hospital Center Lafayette Office | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Cheryl Iglesia, MD | Medstar Health Research Institute |
Responsible Party: | Medstar Health Research Institute |
ClinicalTrials.gov Identifier: | NCT02573883 |
Other Study ID Numbers: |
2016-154 |
First Posted: | October 12, 2015 Key Record Dates |
Last Update Posted: | December 17, 2019 |
Last Verified: | December 2019 |
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