A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus
Vulvar Lichen SclerosusThe 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.
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical...
Vulvar Lichen SclerosusThe study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 260 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 130 cases in the radio frequency observation group and 130 cases in the electric stimulation control group.
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
Vulvar Lichen SclerosusThis study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Carbon Dioxide(CO2)Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen...
Vulva Lichen SclerosusThe 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.
Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
Vulvar Lichen SclerosusThis 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.
Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar...
Chronic Skin DiseaseVulvar Lichen SclerosusThe aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.
Laser Treatment for Vulvar Lichen Sclerosus
Vulvar Lichen SclerosusThe object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus. Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment. Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus. The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic VaginitisVaginal Atrophy4 moreVulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva...
Lichen Sclerosus of VulvaLichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment. Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Vulvar Lichen SclerosusThis is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.