ACTRN12618001802291已完成1 期
Vehicle and Comparator-Controlled, Evaluator-blinded Trialto Evaluate the Safety and Anti-Psoriatic Efficacy of TopicalFormulations of BTX 1308 in Subjects with Psoriasis Vulgarisin a Psoriasis Plaque Test
Botanix Pharmaceuticals Limited0 个研究点目标入组 15 人开始时间: 2018年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •To be included in the study, subjects must meet the following inclusion criteria.
- •1. Subject (or legal guardian) has the ability and willingness to sign a written informed
- •2. Subject is of either gender and 18 years or older
- •3. Subject is in good general health without clinically significant haematological, cardiac,
- •respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as
- •determined by the investigator.
- •4. Subject has psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with
- •up to 3 comparable psoriatic plaque(s) sufficient for 4 treatment fields.
- •5. Subject has the treatment field lesion(s) located on the trunk or extremities (excluding
- •palms/soles); psoriatic lesions on the knees or elbows (joints) are not to be used as
- •treatment fields.
- •6. Identified treatment fields should have a comparable EPB thickness of the psoriatic
- •infiltrate of at least 200 µm. This will be measured on Day 1.
- •7. Subject´s physical examination of the skin must be without disease findings other than
- •psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the
- •outcome of the clinical trial.
- •8. A negative urine pregnancy test (UPT) result for all women if childbearing potential (WOCBP) at the Screening Visit and Baseline Visit, if
- •applicable. A WOCBP is one who is not permanently sterilised or is not postmenopausal.
- •Postmenopausal is defined as 24 months with no menses without an alternative medical
- •9. Sexually active WOCBP must agree to use the following throughout the study and for 30
- •days after last study drug application:
- •a. One of these highly effective contraception methods
- •i. Intrauterine device (IUD); hormonal (injections, implants, transdermal
- •patch, vaginal ring; tubal ligation; partner vasectomy, OR
- •b. Oral contraceptives WITH a barrier method (listed below), OR
- •c. Two barrier forms of contraception (listed below)
- •i. Male or female condom; diaphragm; cervical cap.
- •10. Subject is able and willing to complete the study and to comply with all study instructions
- •and attend the necessary visits.
- •11. Male subjects and their partners must agree and commit to use a barrier method of
- •contraception during the study and for 90 days after last study drug application.
- •12. Male subjects must refrain from sperm donation during the study treatment period until 90
- •days after final study drug administration
排除标准
- •If a subject meets any of the following exclusion criteria, they may not participate in the study.
- •1. Subject has other skin disease noted on physical examination that is considered by the
- •investigator to be relevant to the outcome of the trial.
- •2. Subject has acute guttate psoriasis, erythrodermatic psoriasis or pustular psoriasis.
- •3. Subject has used any topical anti-psoriatics on plaques potentially to be treated in this trial
- •(including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol
- •and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the
- •4 weeks before the Baseline Visit.
- •4. Subject has used systemic treatment with anti-psoriatics e.g., corticosteroids, cytostatics,
- •or retinoids in the three months before the Baseline Visit.
- •5. Subject has used biologicals (e.g., ustekinumab, secukinumab, ixekizumab, guselkumab,
- •adalimumab, infliximab and etanercept) within six months before the Baseline Visit.
- •6. Subject has used UV-therapy within four weeks before the Baseline Visit.
- •7. Subject has had treatment with any concomitant medication that may affect and provoke
- •or aggravate psoriasis, e.g., antimalarial drugs, lithium, beta-blockers or ACE inhibitors
- •unless on a stable dose for 3 months before the Baseline Visit.
- •8. Subject has known allergic reactions, irritations or sensitivity to the active ingredients or
- •other components of the study drugs.
- •9. Subject has contraindications according to summary of product characteristics for
- •betamethasone valerate, the active comparator.
- •10. Subject is receiving treatment with anticoagulant drugs (biopsy group only), which in the
- •opinion of the investigator will be of concern for the biopsy procedure.
- •11. Subject has HIV or active virus hepatitis (only applicable for subjects consenting to biopsy
- •12. Subject has positive pregnancy test or is nursing.
- •13. Subject has a history or symptoms of a clinically significant illness in the 4 weeks before
- •first treatment and during the trial that in the opinion of the investigator may place the
- •subject at risk by trial participation or influence the outcome of the trial.
- •14. Subject has blood pressure above 160 mm Hg (systolic) and/or 95 mm Hg (diastolic) at the
- •Screening Visit.
- •15. Subject is participating or has participated in the treatment phase of another clinical trial
- •within the last 4 weeks prior to the Baseline Visit.
- •16. Subject has a clinically relevant history or currently suffering from any disease or condition
- •that, in the opinion of the investigator, may affect the evaluation of the study product or
- •place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological,
- •lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,
- •immunological, or connective tissue diseases or disorders.
- •17. Any other reason that would make the subject, in the opinion of the investigator or sponsor,
- •unsuitable for the study.
研究者
相似试验
进行中（未招募）
不适用
Trial to evaluate whether a 5 % diclofenac gel formula is effective and safe to use for treating actinic keratosis; tested in comparison to a standard treatment (gel) and a 'placebo' gel; conducted by numerous practises / hosptitals, and in a fashion that neither doctor nor patient knows who receives the new treatment, the standard treatment, and the placebo treatment.EUCTR2010-022244-20-GBAlmirall S.A.824
进行中（未招募）
不适用
Trial to evaluate whether a 5 % diclofenac gel formula is effective and safe to use for treating actinic keratosis; tested in comparison to a standard treatment (gel) and a 'placebo' gel; conducted by numerous practises / hosptitals, and in a fashion that neither doctor nor patient knows who receives the new treatment, the standard treatment, and the placebo treatment.Patients aged 18 and older suffering from actinic keratosis. Patients to be considered have at least 6 but no more than 16 clinically confirmed AK target lesions of mild to moderate intensity in up to 3 treatment areas (TAs) with a size of 25 cm2 per TA (i.e. total size of TA is up to 75 cm2) and additionally one representative AK lesion for histological diagnosis of AK, which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp.MedDRA version: 14.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2010-022244-20-DEAlmirall S.A.824
已完成
不适用
A randomized, evaluator-blind, vehicle controlled, parallel group study to explore the effects of the anti-inflammatory drug prednisolone in a TLR4 and TLR7 challenge model in healthy volunteersNL-OMON55304Centre for Human Drug Research60
进行中（未招募）
1 期
Anti-inflammatory drugs in a TRL4 and TLR7 topical challenge modelEUCTR2019-003567-21-NLCentre for Human Drug Research60
已完成
不适用
A randomized, evaluator-blinded, vehicle-controlled study to explore the pharmacodynamic effects of omiganan and omiganan in combination with imiquimod in healthy volunteers.dermatological challenge modelskin inflammation model10040790NL-OMON45716Cutanea Life Sciences16