EUCTR2017-003722-33-IT进行中（未招募）1 期
Safety and Efficacy of Rifaximin Delayed Release 400 mg Tablets in Patients with Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test. A Multicenter Double-Blind, Placebo-Controlled Randomized Clinical Trial. - REROS TRIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All the following criteria must be met both at the Screening (V1) and the Randomization (V2) visit unless otherwise specified.
- •1)Men and women aged 18 to 70 years at screening (V1)
- •2)Female participants are eligible if they are:
- •of non-childbearing potential, i.e.: i) post-menopausal (at least 2 years without spontaneous menses), or ii) surgically sterile (bilateral tubal occlusion, or hysterectomy), or iii) ablation of both ovaries or
- •of childbearing potential with a negative pregnancy test result at screening and randomization and agreeing to use a highly effective method of contraception (i.e. with failure rate of less than 1% per year) until 72 hours after taking the last study treatment dose.
- •3)Moderate-to-severe papulopustular rosacea (a.k.a. subtype II, RII,) at screening and confirmed at randomization. Moderate-to-severe rosacea is defined as the presence of 11 or more facial papules or pustules with or without plaques.
- •4)Positivity of lactulose H2/CH4 breath test (L-BT) within the last 2-weeks before randomization.
- •5)Patients accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol (including facial skin photography).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •All the following criteria must be met both at the Screening (V1) and the Randomization (V2) visit unless otherwise specified.
- •1)Granulomatous rosacea or rosacea fulminans.
- •2)Erythematoteleangectatic, phymatous or ocular rosacea only. Patients with these subtypes associated with papulopustular rosacea can be enrolled.
- •3)Circulating anti-helicobacter pylori IgM and/or IgG at screening (V1).
- •4)Positivity at the faecal Clostridium Difficile toxin assay at screening (V1).
- •5)History or family history of inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or other conditions characterized by severe intestinal ulcers.
- •6)History or family history of coeliac disease.
- •7)Patients with intestinal obstruction or partial intestinal obstruction.
- •8)Presence of diarrhoea associated with fever and/or blood in the stool.
- •9)Health conditions requiring continuous or intermittent treatment with facial topical, inhaled or systemic steroids and/or biologic or non-biologic immunosuppressive or immunomodulatory agents (e.g. autoimmune diseases, etc.).
- •10)Severe kidney impairment (i.e. estimated glomerular filtration rate <30 ml/min).
- •11)Severe hepatic impairment (i.e. Child-Pugh B or C).
- •12)Cancer or any cancer-related treatment within 5 years prior to screening (excluding non-melanoma skin-cancer).
- •13)History of alcohol or drug abuse within a year prior to screening.
- •14)Facial skin conditions that can interfere with reliable assessment of rosacea throughout the study (e.g. keloids, hypertrophic scarring, recent facial surgery etc.)
- •15)Any other significant health condition (e.g. cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, hematologic, oncologic, immune etc.) that in the investigator’s judgement may:
- •i)jeopardize the patient’s safe participation in the trial or
- •ii)make unlikely the patient’s completion of the study or
- •iii)make unlikely the patient’s compliance with the study procedures (e.g. highly anticipated need of non-permitted treatments, terminal illness, etc.).
- •16)History of hypersensitivity to rifaximin, rifamycin-derivatives, any of the rifaximin-EIR excipients, or any UV protection cream component.
- •17)Treatment with biologic immunomodulatory and/or immunosuppressive drugs (e.g. anti-TNF drugs) within 6 months prior to randomization.
- •18)Treatment with non-biologic immunomodulatory and/or immunosuppressive drugs (e.g. cyclosporine, methotrexate etc.) within 30 days prior to randomization.
- •19)Treatment with warfarin within 14 days prior to randomization.
- •20)Treatment with niacin within 30 days prior to randomization.
- •21)Topical facial or systemic antibiotics within 30 days before randomization;
- •22)Treatment with neomycin or other low-absorbable oral antibiotics (such as marketed rifaximin) within 90 days before randomization.
- •23)Topical facial, inhaled or systemic corticosteroids within 30 days prior to randomization.
- •24)Topical facial retinoids within 30 days before randomization.
- •25)Systemic retinoids within 6 months before randomization.
- •26)Any other topical or systemic treatment for rosacea within 30 days before randomization (including also laser and pulsed light, etc.).
- •27)Pharmaceutical prebiotics and probiotics (functional food is allowed), within 30 days before randomization.
- •28)Any experimental treatment within 6 months prior to randomization.
- •29)Women who are pregnant, breast-feeding or planning a pregnancy during the trial period.
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