CuRLS: Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
Sponsor
Medstar Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02573883
Collaborator
(none)
52
1
2
47
1.1
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Detailed Description
Vulvar lichen sclerosus (LS) is a well-characterized dermatosis resulting in labial atrophy, synechiae and introital narrowing and can often cause dyspareunia, itching and co-existent vulvar pain. Biopsy is necessary to confirm the clinical diagnosis and the mainstay of treatment usually consists of topical steroid therapy (Chi). Clobetasol propionate and mometasone furoate are potent topical steroids that have long been considered gold-standard treatment for vulvar lichen sclerosus and work through anti-inflammatory, anti-mitotic, and immunosuppressive effects. One of the complications of long-term steroid use, however, is potential thinning of the vulvar skin, therefore limiting long-term use. Clobetasol propionate has a range of efficacy from 61-91% depending on the selected outcome criteria.
The vulvovaginal SmartXide -V2-LR laser system by DEKA (Calezano, Italy) is a fractionated C02 laser with maximum 40 Watt power and laser energy emission at 10,600 nanometer wavelength which is mainly absorbed by water in the underlying tissue (Salvatore). The SmartXide-V2-LR system was first introduced in 2009 with DOT therapy distributing fractioned CO2 laser in small spots of 200 microns to the vulvar skin or vaginal epithelium, resulting in a portion of the skin remaining intact with less tissue destruction and faster healing (Salvatore). The device is cleared by the US Food and Drug Administration (FDA) for incision, excision, ablation, and coagulation of gynecologic soft tissues. The fractioned therapy has been shown to stimulate fibroblastic growth through activation and biosynthesis of collagen and restoration of the extracellular matrix with collagen fibers.
Very little is known about long-term effects of fractionated C02 laser therapy use in the vulva or vagina, although the treatment is widely accepted in plastic and cosmetic surgery and dermatology. Increased marketing for laser vaginal rejuvenation has spawned a proprietary female genital cosmetic surgery industry in the US with very limited published outcome data. SmartXide -V2-LR has some established outcome data for treatment of genitourinary syndrome of menopause (GSM), also known as vulvovaginal atrophy (Salvatore).
The purpose of this study is to compare the safety and efficacy of clobetasol propionate .05% ointment to fractionated CO2 laser procedure for the treatment of vulvar lichen sclerosus. Women presenting to the urogynecology clinic will be screened for lichen sclerosus. Vulvar biopsy will be performed for confirmation, and, if eligible, the patient will be consented to undergo baseline questionnaires, photodocumentation of vulvar lesions and randomization. A minimum of 2 weeks are required from the time of biopsy to treatment. Patient will be randomized to monthly LASER treatment for 3 months or topical STEROID therapy (clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) in a 1:1 ratio using a computer generated randomization schedule. Because of the nature of the treatment, it will not be possible to blind patients but the assessor will be blinded to the intervention. Patients may have used clobetasol propionate in past, but must complete 8 week wash out period.
Patient questionnaires include multiple validated scales and surveys to provided reproducible measures of vulvar symptoms as primary and secondary outcomes. Questionnaires will be completed at the intake visit, repeated at 6 month and one year follow up. The investigators expect improved subjective and objective results in the LASER group at 6 months compared with the STEROID group. At 6 months, participants are giving the option to crossover to receive the other treatment arm if desired due to continued symptoms. All groups are followed to 12 months for comparison.
Sample size calculations were conducted using the absolute change in the Skindex 29 as the primary end point. Out study will reach 80% power to detect a mean difference of 16 points on the Skindex 29 (sd=22 for both groups) between the study groups with 25 patients in each group, or 50 in total based on a one-sided two-sample t-test with alpha=0.05 (He). By accounting for 10% attrition, the investigators propose to recruit 56 patients to the study to be randomized with a 1:1 ratio to each group, with a blocked component for those who used tropical clobetasol in the past.
Data will be entered into a secure RedCAPS Database which provides complete auditing for data management processes. De-identified backup data will be kept in locked files at the participating site. Plans for publication will be handled by the investigators at MedStar Washington Hospital Center and will adhere to publication policies. All personnel with access to data collected have completed the Program for Ethics Education in Research training with the appropriate HIPAA certification.
Patients will not be compensated for travel and may be accountable for some medical bills for office visits. Study location is Medstar Lafayette Office 1133 21st St NW, Washington, DC 20036.
Study Design
Study Type:
Interventional
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
:
Oct 1, 2015
Actual Primary Completion Date
:
Sep 1, 2019
Actual Study Completion Date
:
Sep 1, 2019
Arms and Interventions
| 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:
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 Names:
|
| 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:
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Change in SkinDEX-29 Score [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
- Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [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.
- Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [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.
- Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score [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.
- Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score [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.
- Change Vaginal Health Index (VHI) Score [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.
- Change Vaginal Health Index (VHI) Score [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.
- Change Vulvar Symptom Visual Analog Scale (VAS) Score [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.
- Change Vulvar Symptom Visual Analog Scale (VAS) Score [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).
- Change SkinDEX-29 Score [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.
- Change Objective Provider VAS Visual Analog Scale [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.
- Change Objective Provider VAS Visual Analog Scale [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.
- Number of Patients With Adverse Outcomes [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
- Number of Patients With Adverse Outcomes [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.
- Number of Patients With Adverse Outcomes [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medstar Washington Hospital Center Lafayette Office | Washington | District of Columbia | United States | 20010 |
Sponsors and Collaborators
- Medstar Health Research Institute
Investigators
- Principal Investigator: Cheryl Iglesia, MD, Medstar Health Research Institute
Study Documents (Full-Text)
More Information
Publications
- Chi CC, Kirtschig G, Baldo M, Brackenbury F, Lewis F, Wojnarowska F. Topical interventions for genital lichen sclerosus. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD008240. doi: 10.1002/14651858.CD008240.pub2. Review.
- He Z, Lu C, Chren MM, Zhang Z, Li Y, Ni X, Buchtel V HA, Ryan PF, Li GZ. Development and psychometric validation of the Chinese version of Skindex-29 and Skindex-16. Health Qual Life Outcomes. 2014 Dec 24;12:190. doi: 10.1186/s12955-014-0190-4.
- Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT02573883
Other Study ID Numbers:
- 2016-154
First Posted:
Oct 12, 2015
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Medstar Health Research Institute
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from urogynecologic and gynecology academic center office visits with vulvar biopsy-proven lichen sclerosus. Patients underwent block randomization with a 1:1 ratios, with stratification for participants based on prior clobetasol use. Participates stayed in randomized group until six months when they had the option to crossover into other treatment group and receive that treatment or continue to 12 months with current treatment. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Clobetasol Propionate- No Crossover | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Period Title: Six Month Follow Up | ||||
| STARTED | 25 | 27 | 0 | 0 |
| COMPLETED | 24 | 27 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 0 | 0 |
| Period Title: Six Month Follow Up | ||||
| STARTED | 13 | 17 | 11 | 10 |
| COMPLETED | 11 | 16 | 11 | 10 |
| NOT COMPLETED | 2 | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate | Total |
|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 | Total of all reporting groups |
| Overall Participants | 27 | 25 | 52 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.6
(11)
|
61.5
(8.9)
|
64.5
(10.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
100%
|
25
100%
|
52
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
11.1%
|
6
24%
|
9
17.3%
|
| White |
23
85.2%
|
17
68%
|
40
76.9%
|
| More than one race |
1
3.7%
|
0
0%
|
1
1.9%
|
| Unknown or Not Reported |
0
0%
|
2
8%
|
2
3.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
27
100%
|
25
100%
|
52
100%
|
| Prior Clobetasol Exposure (Count of Participants) | |||
| Count of Participants [Participants] |
14
51.9%
|
11
44%
|
25
48.1%
|
Outcome Measures
| Title | Change in SkinDEX-29 Score |
|---|---|
| Description | 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). |
| Time Frame | Change from baseline score to score at six months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Mean (Standard Deviation) [score on a scale] |
-16.83
(18.09)
|
-5.92
(5.81)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fractionated Carbon Dioxide Laser, Clobetasol Propionate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) |
|---|---|
| Description | 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. |
| Time Frame | Baseline to six months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Mean (Standard Deviation) [score on a scale] |
-3.92
(4.12)
|
-0.58
(5.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fractionated Carbon Dioxide Laser, Clobetasol Propionate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) |
|---|---|
| Description | 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. |
| Time Frame | Six month to one year after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need |
| Measure Participants | 16 | 11 | 11 | 10 |
| Mean (Standard Deviation) [score on a scale] |
0.44
(4.43)
|
0.3
(2.41)
|
-1.82
(3.66)
|
-2.9
(3.98)
|
| Title | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score |
|---|---|
| Description | 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. |
| Time Frame | Six months from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Count of Participants [Participants] |
21
77.8%
|
9
36%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fractionated Carbon Dioxide Laser, Clobetasol Propionate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score |
|---|---|
| Description | 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. |
| Time Frame | 1 year from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Measure Participants | 16 | 11 | 11 | 10 |
| Count of Participants [Participants] |
14
51.9%
|
4
16%
|
9
17.3%
|
10
NaN
|
| Title | Change Vaginal Health Index (VHI) Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 6 months after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Mean (Standard Deviation) [score on a scale] |
1.92
(4.34)
|
-0.43
(3.62)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fractionated Carbon Dioxide Laser, Clobetasol Propionate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change Vaginal Health Index (VHI) Score |
|---|---|
| Description | 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. |
| Time Frame | Six month to one year after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need |
| Measure Participants | 16 | 11 | 11 | 10 |
| Mean (Standard Deviation) [score on a scale] |
-2.86
(4.37)
|
1.44
(4.45)
|
1.73
(2.83)
|
1.3
(4.3)
|
| Title | Change Vulvar Symptom Visual Analog Scale (VAS) Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 6 months after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Itching |
-3.26
(3.75)
|
-1.83
(2.75)
|
| Burning |
-2.78
(3.76)
|
-1.00
(3.21)
|
| Irritation |
-4.15
(4.04)
|
-1.32
(2.84)
|
| Pain with sex |
-0.69
(2.95)
|
-0.14
(1.35)
|
| Tearing of vulvar skin |
-1.77
(3.55)
|
-1.32
(4.07)
|
| Dysuria |
-2.11
(3.47)
|
-0.78
(2.37)
|
| Pain defecation |
-1.11
(2.83)
|
-0.78
(2.67)
|
| Title | Change Vulvar Symptom Visual Analog Scale (VAS) Score |
|---|---|
| Description | 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). |
| Time Frame | Six months to one year after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Measure Participants | 16 | 11 | 11 | 10 |
| Itching |
-0.8
(3.76)
|
-0.1
(3.03)
|
-1.82
(3.06)
|
0.89
(4.76)
|
| Burning |
-0.73
(3.43)
|
-1.5
(3.87)
|
-0.73
(4.45)
|
-0.9
(2.6)
|
| Irritation or tearing |
-0.38
(4.03)
|
-1
(3.54)
|
-1.64
(2.69)
|
0.67
(3.71)
|
| Pain with sex |
-1.12
(4.26)
|
0
(0)
|
-1.62
(3.25)
|
-2
(4)
|
| Tearing of vulvar skin |
-0.14
(3.8)
|
-0.8
(2.66)
|
-2.12
(3.14)
|
-0.22
(1.99)
|
| Dysuria |
-0.5
(4.77)
|
-0.2
(3.97)
|
-1.27
(2.94)
|
-0.4
(0.84)
|
| Painful defecation |
0
(3.21)
|
-0.57
(3.98)
|
-0.09
(1.38)
|
-0.89
(1.36)
|
| Title | Change SkinDEX-29 Score |
|---|---|
| Description | 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. |
| Time Frame | Six months to one year from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Measure Participants | 16 | 11 | 11 | 10 |
| Mean (Standard Deviation) [score on a scale] |
-0.78
(25.94)
|
-7.05
(22.13)
|
-10.23
(17.53)
|
-1.52
(11)
|
| Title | Change Objective Provider VAS Visual Analog Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline to Six months from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| White Plaque |
-1.81
(1.70)
|
-1.3
(1.96)
|
| Cigarette Paper |
-2.58
(1.92)
|
-1.5
(1.9)
|
| Introital Narrowing |
-1.73
(2.82)
|
-0.70
(2.16)
|
| Perianal Involvement |
-0.73
(3.49)
|
-1.77
(3.35)
|
| Loss of Labial Minora |
-0.96
(2.44)
|
-0.78
(2.26)
|
| Fusion of Labia Minora |
-0.5
(2.5)
|
0.35
(2.92)
|
| Phimosis |
-1.28
(2.3)
|
0.22
(2.04)
|
| Fissure |
-2.12
(2.4)
|
-1.78
(2.41)
|
| Erosion |
-2.08
(2.86)
|
-0.57
(1.88)
|
| Title | Change Objective Provider VAS Visual Analog Scale |
|---|---|
| Description | 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. |
| Time Frame | Six months to One Year from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Measure Participants | 16 | 11 | 11 | 10 |
| White Plaque |
-0.71
(3.29)
|
-1.25
(1.49)
|
-0.27
(2.24)
|
-0.22
(1.45)
|
| Cigarette Paper |
0.07
(3.1)
|
0.38
(1.6)
|
-0.45
(1.81)
|
-0.2
(1.48)
|
| Introital Narrowing |
0
(2.6)
|
0.88
(2.53)
|
-0.18
(0.52)
|
-0.1
(2.42)
|
| Perianal Involvement |
-0.77
(4.07)
|
0.29
(1.7)
|
0.64
(4.7)
|
-1.4
(1.9)
|
| Loss of Labial Minora |
0.5
(2.9)
|
-0.5
(1.69)
|
0.73
(2.8)
|
1.2
(2.9)
|
| Fusion of Labia Minora |
0.14
(2.54)
|
-0.25
(1.91)
|
-1.09
(2.59)
|
-1
(2.83)
|
| Phimosis |
1.43
(2.21)
|
-0.5
(1.69)
|
-0.18
(1.66)
|
0.2
(2.53)
|
| Fissure |
0.07
(2.53)
|
0.62
(1.06)
|
-0.45
(2.62)
|
-1.4
(2.32)
|
| Erosion |
1
(2.8)
|
0.12
(0.35)
|
-0.36
(1.03)
|
-0.6
(1.9)
|
| Title | Number of Patients With Adverse Outcomes |
|---|---|
| Description | 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 |
| Time Frame | Six Month to One Year from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser- No Crossover | Clobetasol Propionate- No Crossover | Clobetasol Propionate to Laser Crossover | Fractionated Carbon Dioxide Laser to Clobetasol Crossover |
|---|---|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then no further treatment. | 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 then as need. Participants did not cross over. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. |
| Measure Participants | 16 | 11 | 11 | 10 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
| Title | Number of Patients With Adverse Outcomes |
|---|---|
| Description | 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. |
| Time Frame | 12 Weeks to Six months from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Patients With Adverse Outcomes |
|---|---|
| Description | 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. |
| Time Frame | 12 Weeks from treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Please see adverse events section for description of adverse events. |
| Arm/Group Title | Fractionated Carbon Dioxide Laser | Clobetasol Propionate |
|---|---|---|
| Arm/Group Description | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | 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 |
| Measure Participants | 27 | 24 |
| Count of Participants [Participants] |
1
3.7%
|
1
4%
|
Adverse Events
| Time Frame | Adverse events were collected at 12 weeks, six months, and one year post treatment | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Clobetasol Propionate- 0-6 Months | Fractionated Carbon Dioxide Laser- 0-6 Months | Clobetasol Propionate to Laser Crossover 6-12 Months | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | Clobetasol Propionate - No Crossover 6-12 Months | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | ||||||
| Arm/Group Description | 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 then as need. | Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate 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. | Participants previously in the Clobetasol Propionate 0.05% ointment group. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. 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. | Participants previously in the Fractionated Carbon Dioxide Laser group choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. 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 then as need. | Clobetasol Propionate 0.05% ointment Topical Steroid therapy (Clobetasol propionate .05% ointment continued as need. No Crossover. | Participants previoulsly treated with Fractionated Carbon Dioxide Laser choose to not undergo any further treatment. | ||||||
All Cause Mortality |
||||||||||||
| Clobetasol Propionate- 0-6 Months | Fractionated Carbon Dioxide Laser- 0-6 Months | Clobetasol Propionate to Laser Crossover 6-12 Months | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | Clobetasol Propionate - No Crossover 6-12 Months | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/24 (0%) | 0/11 (0%) | 0/10 (0%) | 0/11 (0%) | 0/16 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Clobetasol Propionate- 0-6 Months | Fractionated Carbon Dioxide Laser- 0-6 Months | Clobetasol Propionate to Laser Crossover 6-12 Months | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | Clobetasol Propionate - No Crossover 6-12 Months | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/24 (0%) | 0/11 (0%) | 0/10 (0%) | 0/11 (0%) | 0/16 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Clobetasol Propionate- 0-6 Months | Fractionated Carbon Dioxide Laser- 0-6 Months | Clobetasol Propionate to Laser Crossover 6-12 Months | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | Clobetasol Propionate - No Crossover 6-12 Months | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/27 (3.7%) | 1/24 (4.2%) | 0/11 (0%) | 0/10 (0%) | 0/11 (0%) | 0/16 (0%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| minor burning and blistering at treatment site | 0/27 (0%) | 0 | 1/24 (4.2%) | 1 | 0/11 (0%) | 0 | 0/10 (0%) | 0 | 0/11 (0%) | 0 | 0/16 (0%) | 0 |
| Activation Genital Herpes | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 | 0/11 (0%) | 0 | 0/10 (0%) | 0 | 0/11 (0%) | 0 | 0/16 (0%) | 0 |
Limitations/Caveats
The study was unblinded for patients and evaluators and only performed at a single center. The steroid group had more non-compliant patients (25% vs 4%). We limited our investigation to only postmenopausal women Further research using placebo and sham lasers for treatment blinding is needed. Patients previously using topical vaginal estrogen were continued on prior treatment, groups were not stratified based on estrogen exposure, however there where equal numbers between groups.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Cheryl Iglesia |
|---|---|
| Organization | Medstar Health Research Institute |
| Phone | 202-877-6526 |
| cheryl.iglesia@medstar.net |
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT02573883
Other Study ID Numbers:
- 2016-154
First Posted:
Oct 12, 2015
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021