Vulvar Lichen Sclerosus
Conditions
Keywords
MonaLisa Touch, fractionated laser, SMARTXIDE2
Brief summary
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Detailed description
Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.
Interventions
DEVICEMonaLisa Touch
3 laser treatments at 6 week intervals for 6 months by a single trained operator
DRUGTopical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%
Sponsors
University of South Alabama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores \>21
Exclusion criteria
* prior vaginal mesh or pelvic radiation * active genital infection * Current or past gynecologic malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skindex-29 Score | Completed by the subject at baseline and 6 months. | The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | Administered at baseline and at 6 months by the provider. | This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement. |
| Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | Administered at baseline and at 6 months by the provider. | A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement. |
| Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | Administered at baseline and at 6 months by the provider. | A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement. |
| Change in Objective Visual Analog Scale | Scored by the provider at baseline and 6 months | Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement. |
| Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | Administered at baseline and 6 months by an investigator to the subject | A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement. |
| Change in Symptom Subjective Visual Analog Score | Administered at baseline and 6 months by an investigator to the subject | This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms. |
| Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | Administered at baseline and at 6 months by the provider. | A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fractionated CO2 Laser Plus Topical Steroids 3 laser treatments at 6 week intervals for 6 months by a single trained operator
MonaLisa Touch: 3 laser treatments at 6 week intervals for 6 months by a single trained operator
Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05% | 6 |
| Topical Steroids Alone self-applied topical steroid therapy using clobetasol propionate 0.05%
Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05% | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Fractionated CO2 Laser Plus Topical Steroids | Topical Steroids Alone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Change in Skindex-29 Score
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.
Time frame: Completed by the subject at baseline and 6 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Skindex-29 Score | Decrease in Skindex-29 Score | 3 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Skindex-29 Score | Increase in Skindex-29 Score | 1 Participants |
| Topical Steroids Alone | Change in Skindex-29 Score | Decrease in Skindex-29 Score | 3 Participants |
| Topical Steroids Alone | Change in Skindex-29 Score | Increase in Skindex-29 Score | 2 Participants |
Secondary
Change in Objective Visual Analog Scale
Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.
Time frame: Scored by the provider at baseline and 6 months
Population: If scale was not completed at either visit, that participant's data was not included in the outcome measure data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Objective Visual Analog Scale | Decrease in score | 3 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Objective Visual Analog Scale | Increase in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Objective Visual Analog Scale | No change in score | 1 Participants |
| Topical Steroids Alone | Change in Objective Visual Analog Scale | Decrease in score | 4 Participants |
| Topical Steroids Alone | Change in Objective Visual Analog Scale | Increase in score | 0 Participants |
| Topical Steroids Alone | Change in Objective Visual Analog Scale | No change in score | 0 Participants |
Secondary
Change in Symptom Subjective Visual Analog Score
This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms.
Time frame: Administered at baseline and 6 months by an investigator to the subject
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Symptom Subjective Visual Analog Score | Decrease in total score | 3 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Symptom Subjective Visual Analog Score | Increase in total score | 1 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Symptom Subjective Visual Analog Score | No change in total score | 0 Participants |
| Topical Steroids Alone | Change in Symptom Subjective Visual Analog Score | Decrease in total score | 2 Participants |
| Topical Steroids Alone | Change in Symptom Subjective Visual Analog Score | Increase in total score | 1 Participants |
| Topical Steroids Alone | Change in Symptom Subjective Visual Analog Score | No change in total score | 1 Participants |
Secondary
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)
A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time frame: Administered at baseline and at 6 months by the provider.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | Decrease in score | 3 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | Increase in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | No change in score | 1 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | Decrease in score | 2 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | Increase in score | 3 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only) | No change in score | 0 Participants |
Secondary
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)
A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time frame: Administered at baseline and at 6 months by the provider.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | Decrease in score | 2 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | Increase in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | No change in score | 2 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | Decrease in score | 1 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | Increase in score | 1 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only) | No change in score | 3 Participants |
Secondary
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)
A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time frame: Administered at baseline and 6 months by an investigator to the subject
Population: Only 1 participant was sexually active at both the initial and final visits.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | No change in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | Decrease in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | Increase in score | 0 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | No change in score | 1 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | Decrease in score | 0 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only) | Increase in score | 0 Participants |
Secondary
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)
A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time frame: Administered at baseline and at 6 months by the provider.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | Decrease in Score | 3 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | Increase in Score | 1 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | No change in score | 0 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | Decrease in Score | 3 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | Increase in Score | 2 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only) | No change in score | 0 Participants |
Secondary
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)
This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time frame: Administered at baseline and at 6 months by the provider.
Population: When scoring the questionnaire, if the participant did not include a score for both the initial and final question, it was not included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | Decrease in score | 4 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | Increase in score | 0 Participants |
| Fractionated CO2 Laser Plus Topical Steroids | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | No change in score | 0 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | Decrease in score | 2 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | Increase in score | 2 Participants |
| Topical Steroids Alone | Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score) | No change in score | 1 Participants |