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Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus (CuRLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573883
Recruitment Status : Completed
First Posted : October 12, 2015
Results First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
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 sclerosus.

Condition or disease Intervention/treatment Phase
Vulvar Lichen Sclerosus Device: Fractionated Carbon Dioxide Laser Drug: Clobetasol Propionate 0.05% ointment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Clobetasol Propionate 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prior Clobetasol Exposure
Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate
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:
  • SmartXide -V2-LR system
  • Mona Lisa Laser

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.
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:
  • SmartXide -V2-LR system
  • Mona Lisa Laser

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




Primary Outcome Measures :
  1. Change in SkinDEX-29 Score [ Time Frame: Change from baseline score to score at six months ]
    The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement in symptoms (better outcome).


Secondary Outcome Measures :
  1. Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [ Time Frame: Baseline to six months ]
    Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement.

  2. Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [ Time Frame: Six month to one year after treatment ]
    Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement.

  3. Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score [ Time Frame: Six months from treatment ]
    Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction.

  4. Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score [ Time Frame: 1 year from treatment ]
    Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction.

  5. Change Vaginal Health Index (VHI) Score [ Time Frame: Baseline to 6 months after treatment ]
    The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points.

  6. Change Vaginal Health Index (VHI) Score [ Time Frame: Six month to one year after treatment ]
    The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points.

  7. Change Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Baseline to 6 months after treatment ]
    Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

  8. Change Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Six months to one year after treatment ]
    Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement in symptoms (better outcome).

  9. Change SkinDEX-29 Score [ Time Frame: Six months to one year from treatment ]
    The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement.

  10. Change Objective Provider VAS Visual Analog Scale [ Time Frame: Baseline to Six months from treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

  11. Change Objective Provider VAS Visual Analog Scale [ Time Frame: Six months to One Year from treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

  12. Number of Patients With Adverse Outcomes [ Time Frame: Six Month to One Year from treatment ]
    Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment

  13. Number of Patients With Adverse Outcomes [ Time Frame: 12 Weeks to Six months from treatment ]
    Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment.

  14. Number of Patients With Adverse Outcomes [ Time Frame: 12 Weeks from treatment ]
    Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, District of Columbia
Medstar Washington Hospital Center Lafayette Office
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Principal Investigator: Cheryl Iglesia, MD Medstar Health Research Institute
  Study Documents (Full-Text)

Documents provided by Medstar Health Research Institute:
Informed Consent Form  [PDF] April 4, 2018

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02573883    
Other Study ID Numbers: 2016-154
First Posted: October 12, 2015    Key Record Dates
Results First Posted: October 12, 2021
Last Update Posted: October 12, 2021
Last Verified: October 2021
Keywords provided by Medstar Health Research Institute:
Vulva
Lichen Sclerosus
Fractionated Carbon Dioxide Laser
Mona Lisa Laser
Clobetasol Propionate
Vulvodynia
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs