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Inability to obtain recruitment levels needed for study to continue.
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This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated CO2 laser plus topical steroids | Experimental | 3 laser treatments at 6 week intervals for 6 months by a single trained operator |
|
| topical steroids alone | Active Comparator | self-applied topical steroid therapy using clobetasol propionate 0.05% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MonaLisa Touch | Device | 3 laser treatments at 6 week intervals for 6 months by a single trained operator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Completed by the subject at baseline and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Hanes, MD | Adjunct Associate Professor of Obstetrics and Gynecology | Principal Investigator |
| Stephen Varner, MD | Associate Professor of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Health Children's and Women's Hospital | Mobile | Alabama | 36604 | United States | ||
| USA Health Strata Patient Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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% |
| FG001 | 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% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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% |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Completed by the subject at baseline and 6 months. |
|
6 months
Reporting Adverse Events Investigators are required to report all AEs experienced by subjects from the time of enrollment until the subject completes the study or terminates early. All AEs, regardless of their relatedness to the study device must be reported. The investigator will evaluate the intensity of the event, severity of the event, and its relatedness to the study device or procedure. All AEs must be followed until resolution or until they become stable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catera Duhon | USA Health | 251-415-1598 | cduhon@health.southalabama.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2021 | Jun 3, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
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| Topical steroid | Drug | self-applied topical steroid therapy using clobetasol propionate 0.05% |
|
|
| Scored by the provider at baseline and 6 months |
| 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. | Administered at baseline and at 6 months by the provider. |
| 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. | Administered at baseline and at 6 months by the provider. |
| 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. | Administered at baseline and at 6 months by the provider. |
| 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. | Administered at baseline and at 6 months by the provider. |
| 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. | Administered at baseline and 6 months by an investigator to the subject |
| 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. | Administered at baseline and 6 months by an investigator to the subject |
| Mobile |
| Alabama |
| 36604 |
| United States |
| 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% |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
self-applied topical steroid therapy using clobetasol propionate 0.05% Topical steroid: self-applied topical steroid therapy using clobetasol propionate 0.05% |
|
|
| 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. | If scale was not completed at either visit, that participant's data was not included in the outcome measure data. | Posted | Count of Participants | Participants | Scored by the provider at baseline and 6 months |
|
|
|
| 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. | When scoring the questionnaire, if the participant did not include a score for both the initial and final question, it was not included. | Posted | Count of Participants | Participants | Administered at baseline and at 6 months by the provider. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Administered at baseline and at 6 months by the provider. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Administered at baseline and at 6 months by the provider. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Administered at baseline and at 6 months by the provider. |
|
|
|
| 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. | Only 1 participant was sexually active at both the initial and final visits. | Posted | Count of Participants | Participants | Administered at baseline and 6 months by an investigator to the subject |
|
|
|
| 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. | Posted | Count of Participants | Participants | Administered at baseline and 6 months by an investigator to the subject |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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% | 0 | 5 | 0 | 5 | 0 | 5 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| No change in score |
|
| No change in score |
|
| No change in score |
|
| No change in score |
|
| No change in score |
|
| Increase in score |
|
| No change in total score |
|