CTIS2023-503516-32-00进行中（未招募）1 期
A parallel group (2-arm), randomised, double-blind, 12-week trial to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women diagnosed with vulvar lichen sclerosus (VLS) - MC2-25-C3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
入选标准
- •Women, of any race or ethnicity, who are =18 years of age at the time of Screening 1., Women of childbearing potential must agree to use a highly effective method of contraception (i.e., a method with a failure rate of less than 1 % per year when used consistently and correctly) while receiving double-blind treatment., Able to understand the trial and willing to comply with trial requirements., Has provided written informed consent., Clinical diagnosis of VLS made by either a dermatologist or a gynaecologist familiar with VLS., Presence of at least one of the following signs of VLS: a. Hyperkeratosis (i.e., patches/plaques of bright white skin with a ‘powdery’ texture) and/or b. Sclerosis (i.e., areas of yellowish/ivory white skin with a smooth/waxy/firm texture. Sclerosis is often seen at the tips of the labia minora, or on periclitoral or perineal skin) in at least one of the following vulvar areas: Clitoris and/or periclitoral skin (C); Right interlabial sulcus and labium minus (R); Left interlabial sulcus and labium minus (L); Posterior Fourchette and/or perineum (P), First symptoms of VLS (e.g., itching and/or pain) noticed by the patient at least 6 months before baseline., At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit., At least moderate itch defined as average WI-NRS =4 at the Baseline visit (average WI-NRS is calculated as the average of all available and at least four WI-NRS scores which are to be reported once daily by the patient in the diary for 7 days prior to the Baseline visit, Women must be of either: a) Non-childbearing potential, i.e., post-menopausal* or confirmed sterile (e.g., hysterectomy, bilateral salpingectomy or bilateral oophorectomy) (*Note: a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient) OR, b) Childbearing potential with a negative highly sensitive* urine pregnancy test at the Baseline visit (*Note: a highly sensitive urine pregnancy test must have a sensitivity down to at least 25 mIU/ml for human chorionic gonadotropin (hCG)).
排除标准
- •Pregnant, breast feeding, or planning to become pregnant during the trial., Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit, Start of new or change of menstrual care routines within 21 days prior to the Baseline visit., Use of emollients (including but not limited to creams, ointments, oils, or soaps with emollient properties) on the vulvar region within 3 days prior to the Baseline visit., Use of any topical treatment on the vulvar region, including but not limited to calcineurin inhibitors, corticosteroids or anti-infectives within 14 days prior to the Baseline visit., Use of any light therapy on the vulvar region, including but not limited to UV-B, UV-A, and laser, within 28 days prior to the Baseline visit., Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit., If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol., Previously randomised in this trial., Any (other than VLS) ongoing localised or systemic disease involving the vulvar region – e.g., lichen planus, psoriasis, eczema, ulcerative colitis or known active infection (bacterial, viral or fungal)., Ongoing symptomatic Urinary Tract Infection (UTI)., Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy, Any kind of ongoing cancer (or anti-cancer treatment within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit)., Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial., Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle, Start of a new or change of existing non-biologic systemic treatment, including but not limited to corticosteroids, cyclosporin, methotrexate and tacrolimus, within 21 days prior to the Baseline visit., Start of a new or change of existing biologic systemic treatment, including but not limited to etanercept, adalimumab, alefacept, infliximab, and ustekinumab within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit.
研究者
相似试验
已完成
2 期
People suffering from Chronic Kidney Disease-associated Pruritus (CKD aP) are treated with a new cream, MC2 25 Cream, or placebo (same Cream without active ingredient) for 12 weeks to reduce their burden and to prove the new cream is safe when usedPatients who are on dialysis and experience itch due to this.Skin and Connective Tissue DiseasesChronic Kidney Disease-associated Pruritus (CKD aP)ISRCTN74524864MC2 Therapeutics Ltd108
进行中（未招募）
1 期
A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP)Chronic Kidney Disease associated PruritusMedDRA version: 21.1Level: LLTClassification code: 10060884Term: Uremic pruritus Class: 10040785CTIS2022-500044-38-00Mc2 Therapeutics Limited108
进行中（未招募）
1 期
A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP)CTIS2022-500044-38-01Mc2 Therapeutics Limited108
进行中（未招募）
不适用
A randomized, double-blind, parallell-group, controlled study of topical pentane-1,5-diol hydrogel in patients with impetigoImpetigoEUCTR2005-000808-14-SEAmbria Dermatology88
招募中
1 期
A randomised, double blind, parallel group, comparative Phase I study to evaluate the safety and pharmacokinetics of a single intravenous dose of GB221 compared to Herceptin Registered Trademark (trastuzumab) in healthy volunteers.ACTRN12611001171909Genor Biopharma32