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| Name | Class |
|---|---|
| Patty Brisben Foundation For Women's Sexual Health | OTHER |
| Society of Gynecologic Surgeons | UNKNOWN |
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This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women undergoing FxCO2-laser for vulvar lichen sclerosus.
Primary objective: To evaluate if women with LS who undergo FxCO2 laser therapy and concomitant TCS (clobetasol group) have higher treatment success (defined as a MCID of a ≥16 point improvement in Skindex-29 questionnaire) than those who undergo FxCO2 laser and placebo ointment (placebo group).
Secondary objectives: To compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobetasol Group | Active Comparator | Clobetasol propionate 0.05% ointment is the active treatment arm that will be use in women with lichen sclerosus in the study per standard clinical recommendations. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit). |
|
| Placebo Group | Placebo Comparator | Placebo ointment is the control treatment arm. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated CO2-laser | Device | All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Minimally clinically important difference of a ≥16 point improvement in Skindex-29 validated questionnaire score. Skindex-29 responses are transformed to a linear scale from 0 (no effect) to 100 (effect experienced all the time), and are reported as three scale scores, corresponding to three domains (symptoms, emotions, and functioning). A reduction in Skindex-29 score of 16 points or more has been shown to indicate what is considered a clinically meaningful improvement. | About 5 months (baseline to final visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response - vulvovaginal symptoms | Treatment response - vulvovaginal symptoms will be measured by pre- and post-treatment scores on the vulvovaginal Symptoms Questionnaire, a 21-item survey measuring vulvovaginal symptoms in postmenopausal women. | About 5 months (baseline to final visit) |
| Treatment response - sexual function |
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Inclusion Criteria:
Exclusion Criteria:
Prior surgery with placement vaginal mesh for repair of pelvic organ prolapse (does not include vaginal mesh for anti-incontinence procedure "sling" or prior mesh sacrocolpopexy)
Prior laser, topical immunomodulators or systemic therapy for LS
Active genital infection^
Suspicious vulvar lesion that has not been evaluated
Known vulvar or vaginal malignancy or active treatment for other malignancy
Planning pregnancy or pregnant
Prior pelvic radiation therapy
Topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks*
Contraindication or allergy to clobetasol propionate 0.05%
Currently breast-feeding or lactating
History of poor wound healing, keloids or hypertrophic scarring
History of a skin condition that could interfere with evaluation of efficacy and safety
This study is investigating treatment of vulvar lichen sclerosus and thus participants will be limited to women with vulvar lichen sclerosus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente - Southern California Permanente Medical Group | San Diego | California | 92110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22284137 | Background | Chren MM. The Skindex instruments to measure the effects of skin disease on quality of life. Dermatol Clin. 2012 Apr;30(2):231-6, xiii. doi: 10.1016/j.det.2011.11.003. Epub 2011 Dec 20. | |
| 10782451 | Background | Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. |
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| Clobetasol Propionate 0.05% Ointment | Drug | Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer |
|
|
Treatment response - sexual function will be measured by pre- and post-treatment scores on the Female Sexual Function Index, a validated questionnaire to assess sexual function. |
| About 5 months (baseline to final visit) |
| Treatment response - genital self image | Treatment response - genital self image will be measured by pre- and post-treatment scores on the Female Genital Self Image Scale, a validated survey with scores ranging from 7-28 with higher scores indicate a more positive genital self-image. | About 5 months (baseline to final visit) |
| Treatment response - lower urinary tract function | Treatment response - lower urinary tract function will be measured by pre- and post-treatment scores on the LURN SI-10, a 10-item questionnaire with scores ranging from 0 to 38 (higher scores = worse symptoms/bother). | About 5 months (baseline to final visit) |
| Participant-perceived improvement | Patient Global Impression of Improvement (PGI-I): a one single item question that will ask participants to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." | Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question |
| Participant-perceived treatment satisfaction | Level of satisfaction with treatment: a one single item question that will ask participants to rate their level of satisfaction with treatment on a 5-point Likert scale from "very dissatisfied" to "very satisfied". | Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question |
| MedStar Health |
| Washington D.C. |
| District of Columbia |
| 20036 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| The University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| The Institute for Female Pelvic Medicine & Reconstructive Surgery | Allentown | Pennsylvania | 18103 | United States |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| 21044269 | Background | Herbenick D, Schick V, Reece M, Sanders S, Dodge B, Fortenberry JD. The Female Genital Self-Image Scale (FGSIS): results from a nationally representative probability sample of women in the United States. J Sex Med. 2011 Jan;8(1):158-66. doi: 10.1111/j.1743-6109.2010.02071.x. Epub 2010 Nov 2. |
| 20233278 | Background | Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3. |
| 31135654 | Background | Hodges KR, Wiener CE, Vyas AS, Turrentine MA. The Female Genital Self-image Scale in Adult Women With Vulvar Lichen Sclerosus. J Low Genit Tract Dis. 2019 Jul;23(3):210-213. doi: 10.1097/LGT.0000000000000481. |
| 31364922 | Background | Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31. |
| 23481118 | Background | Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b. |
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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