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Trial record 2 of 25 for:    "Lichen Sclerosus"

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

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ClinicalTrials.gov Identifier: NCT02573883
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : August 20, 2019
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 proprionate .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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [ Time Frame: One year from treatment ]
    Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus

  5. 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

  6. 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

  7. Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to 6 months after treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus total

  8. Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to one year after treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus total

  9. Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to six month after treatment ]
    Visual objective comparison of Lichen Sclerosus

  10. Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to one year after treatment ]
    Visual objective comparison of Lichen Sclerosus

  11. 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

  12. 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

  13. 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



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


Contacts
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Contact: Cheryl Iglesia, MD 202-877-6526

Locations
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United States, District of Columbia
Medstar Washington Hospital Center Lafayette Office Recruiting
Washington, District of Columbia, United States, 20010
Contact: Cheryl B Iglesia, MD    202-877-6526    Cheryl.Iglesia@medstar.net   
Contact: Patricia Tanjutco    (202)877-6526    Joanna.l.peterson@medstar.net   
Sub-Investigator: Linda S Burkett, MD         
Sub-Investigator: Andrew I Sokol, MD         
Sub-Investigator: Amy J Park, MD         
Sub-Investigator: Robert E Gutman, MD         
Sub-Investigator: Lee A Richter, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Principal Investigator: Cheryl Iglesia, MD Medstar Health Research Institute

Publications:
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02573883     History of Changes
Other Study ID Numbers: 2016-154
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Medstar Health Research Institute:
Vulva
Lichen Sclerosus
Fractionated Carbon Dioxide Laser
Mona Lisa Laser
Clobetasol Proprionate
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
Genital Diseases, Female
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs