CTIS2024-511583-82-00进行中（未招募）1 期
A phase III, multicentre, randomised, observer-blind, intraindividual, paired, comparative trial to evaluate the efficacy and safety of a 0.1% mometasone furoate cutaneous emulsion compared to Ecural® fat cream and vehicle cutaneous emulsion in the treatment of adult participants with plaque psoriasis - 410701BS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
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+（—）
- 性别
- All
入选标准
- •Males and non-pregnant, non-lactating females aged 18 to 65 years., Subjects with a confirmed clinical diagnosis of stable plaque (or vulgaris) psoriasis. Severity should be mild at screening, defined as having affected BSA =10%, a PASI =10, and a Dermatology Life Quality Index (DLQI) =10, Subjects must have 2 comparable psoriatic areas for treatment on the extremities or trunk (either symmetrical bilateral, e.g., elbow left and elbow right, or both on one body part if at least 3 cm apart, e.g., upper back and lower back) between 20 and 200 cm2. The larger lesion should not be larger than approximately twice the size of the smaller lesion. Psoriatic lesions on the face and scalp, neck, palms, and soles as well as in intertriginous regions may not be selected as treatment areas., Subjects with a comparable baseline TSS (sum score for erythema, induration, and scaling) of at least 6 of 9 for each of the selected areas (not more than 2 grades difference in TSS between the 2 target lesions)., Female volunteers of childbearing potential must either be permanently sterile or agree to use a highly effective birth control method (failure rate ?1% per year when used consistently and correctly) throughout the clinical trial., Written informed consent obtained.
排除标准
- •Pregnant or breastfeeding women., Acute psoriasis guttata, psoriasis punctata as well as erythrodermic, exfoliative and pustular psoriasis., Findings determined in physical examination and/or vital signs which are considered clinically significant in the opinion of the investigator., History of an allergic reaction or significant sensitivity to constituents of IPs., Contraindications according to the SmPC of the comparator Ecural® fat cream. Of particular note, subjects with a hypersensitivity against soy or peanut should not participate in the clinical trial., Use of topical therapies for the treatment of psoriasis including but not limited to corticosteroids, vitamin D analogues, retinoids during the clinical trial or having discontinued less than 4 weeks prior to randomisation, and (specific to target plaques only) use of urea, salicylic acid, coal tar, and anthralin during the clinical trial or having discontinued less than 2 weeks prior to randomisation., Phototherapy for the treatment of psoriasis including but not limited to: UV-A, UV-B, sunbaths less than 4 weeks, and psoralen and UV-A (PUVA) less than 8 weeks prior to randomisation., History of alcohol or other substance abuse within the last year., In the opinion of the investigator performing the initial examination the subject should not participate in the clinical trial, e.g., due to probable noncompliance or inability to understand nature, meaning, and consequences of the clinical trial and give adequately informed consent., Close affiliation with the investigator (e.g., a close relative) or subject is an employee of sponsor, contract research organisation (CRO) or clinical trial centres., Subject is institutionalised because of legal or regulatory order., Systemic therapies for the treatment of psoriasis including but not limited to cyclosporine, retinoids, methotrexate, tacrolimus, azathioprine, salazosulfapyridine, apremilast, and glucocorticoids less than 4 weeks prior to randomisation., Use of biologic agents for the treatment of psoriasis prior to randomisation as follows: Prohibited medication: Adalimumab, infliximab, brodalumab, ixekizumab, etanercept, guselkumab, certolizumab pegol, golimumab (wash-out period: 3 months); Ustekinumab, alefacept, secukinumab (wash-out period: 6 months); Rituximab (wash-out period: 12 months)., Systemic treatment with any other biological treatments (anti-tumour necrosis factor/interleukin [IL]-12/IL-23 and IL-17 or any other monoclonal antibodies [mAbs]) within the period of 5 half-lives of the biological before first treatment and during the clinical trial., Systemic treatment with janus kinase (JAK) or tyrosine kinase 2 (TYK2) inhibitors within 3 months prior to randomisation., Treatment with systemic or locally acting medications which might counter or influence the aim of the clinical trial (medications which are known to provoke or aggravate psoriasis, e.g., antimalarial drugs, lithium) within 8 weeks before first treatment and/or during the clinical trial. Beta-blockers or angiotensin converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before clinical trial medication initiation., Use of another IP or participation in the treatment phase of a clinical trial within the last 4 weeks prior to first dose or 5 half-life periods if known to be longer., Clinically relevant history or presence of any disease or any chronic medical condition which is not well controlled or surgical history which may interfer
研究者
相似试验
已完成
3 期
A clinical trial to evaluate efficacy and safety of two different formulations of topical Calcipotriol in patients with mild to moderate plaque psoriasis.CTRI/2018/08/015360Cadila Pharmaceuticals Limited278
尚未招募
3 期
Comparison Study of Immunogenicity and Safety of SIBP’s Measles, Mumps and Rubella (MMR) Vaccine versus WHO prequalified GSK Measles, Mumps and Rubella (MMR) VaccinePACTR202405741158761Shanghai Institute of Biological Products Co. Ltd SIBP1,200
进行中（未招募）
不适用
ot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican InfantsPrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virusMedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-004455-39-Outside-EU/EEASanofi Pasteur S.A1,190
进行中（未招募）
不适用
The purpose of the study is to compare and evaluate the generic Brinzolamide ophthalmic suspension with a registered and marketed Brinzolamide ophthalmic suspension as a treatment for ocular hypertension and glaucomaPatients suffering from open angle glaucoma and ocular hypertension with an elevated IOP, higher than 22mmHg and and lower or equal than 35 mmHgEUCTR2011-003692-12-PLAZAD Pharma AG90
已完成
不适用
A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India)Visceral leishmaniasis (VL)Infections and InfestationsISRCTN68386084ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)667