A Randomized Controlled Trial of Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 10
- 主要终点
- Treatment success
研究概览
简要总结
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).
- Hypothesis: A higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo.
- Approach: The proportion of women in each cohort who obtain a ≥16 point improvement in Skindex-29 validated questionnaire score from baseline to final visit will be compared.
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.
- Hypothesis: Women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo.
- Approach: Change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old with biopsy confirmed or clinically diagnosed+ LS
- •English-speaking or Spanish-speaking
- •Electing to undergo Fractionated CO2-laser therapy
- •Willing and able to undergo concomitant 0.05% clobetasol propionate treatment
排除标准
- •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
- •Eligible for inclusion after washout period of 2 weeks ^Eligible for inclusion after treatment. For patients with known genital HSV we will instruct them to remain on suppression for the duration of the study.
研究组 & 干预措施
Clobetasol Group
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).
干预措施: Fractionated CO2-laser (Device)
Clobetasol Group
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).
干预措施: Clobetasol Propionate 0.05% Ointment (Drug)
Placebo Group
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).
干预措施: Fractionated CO2-laser (Device)
结局指标
主要结局
Treatment success
时间窗: About 5 months (baseline to final visit)
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.
次要结局
- Treatment response - sexual function(About 5 months (baseline to final visit))
- Treatment response - vulvovaginal symptoms(About 5 months (baseline to final visit))
- Treatment response - lower urinary tract function(About 5 months (baseline to final visit))
- Treatment response - genital self image(About 5 months (baseline to final visit))
- Participant-perceived treatment satisfaction(Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question)
- Participant-perceived improvement(Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question)