View clinical trials related to Lichen Sclerosus Et Atrophicus.
Filter by:The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
Lichen sclerosus (LS) is a common autoimmune disease of the genital skin. It affects 1/900 women with an age peak in the sixth decade of life and is manifested by chronic inflammation of the genital, perineal, and perianal areas associated with itching, burning, pain, and soreness. In addition, LS is associated with an increased risk of vulvar cancer. Treatment options for LS include topical steroids such as clobetasol, immunomodulators such as tacrolimus, and non-ablative laser treatment. Although both treatments are well documented and used in clinical practice, direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare. For example, a PubMed literature search (search date 2021-03-14; search terms: lichen sclerosus, laser, corticosteroids, steroids, clobetasol, randomized) identified only a single randomized trial with limited power. Given the available evidence, further high-quality studies are needed to define the superiority/inferiority of the different available treatment options such as nonablative lasers and topical corticosteroids. Therefore, in this prospective, randomized, open-label, comparative study, treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 0.05% over 3 months (daily in the first month, every other day in month 2, and 3 times/week during month 3) at the time point 3 months after treatment initiation.
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.
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.
Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant lack of sexual pleasure or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The purpose of this study is to learn the gene expression file changes in skins affected by LS as compared to normal skins in order to discover the mechanism of the LS, and further to develop effective drugs to treat the condition.