Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
研究概览
简要总结
This is an exploratory, single-centre, investigator blinded, randomized, controlled, intra-individual study, involving subjects with psoriasis vulgaris.
The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.
详细描述
Study drugs will be applied in each subject once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below:
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on 2 mini-zones pretreated by a keratolytic product, will be tested:
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CD10367 3% solution
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CD10367 solution placebo
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on 4 mini-zones non-pretreated, will be tested:
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CD10367 3% solution
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CD10367 1% solution
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CD10367 solution placebo
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Betneval 0.1% ointment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit.
- •Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy).
- •Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
- •The subject has a clinical diagnosis of stable plaque psoriasis, defined as no flare during the month before Screening visit and no change between Screening visit and Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit).
- •The subject presents with at least six eligible mini-zones, on at least two psoriasis plaques (Screening visit and verified also at Baseline Visit) with specific severity grades,
- •Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19 visit, (Screening visit)
排除标准
- •The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).
- •The subject has any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).
- •The subject has known or suspected allergies or sensitivities to any components of the study drugs or of the keratolytic product (see Investigator's Brochure/Product label). (Screening visit).
- •The subject has known history of adverse drug reaction or hypersensitivity to a product with the same mode of action
- •The subject has any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
- •The subject presents any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),
- •The subject has QTc interval >450msec or any abnormal ECG value considered as clinically significant by the cardiologist (Screening visit).
- •The subject has received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.
研究组 & 干预措施
CD10367 3% Solution - Desquamated zone
干预措施: CD10367 3% Solution - Desquamated zone (Drug)
CD10367 3% Solution - Non-desquamated zone
干预措施: CD10367 3% Solution - Non-desquamated zone (Drug)
CD10367 1% Solution - Non-desquamated zone
干预措施: CD10367 1% Solution - Non-desquamated zone (Drug)
CD10367 solution placebo - Non-desquamated zone
CD10367 solution placebo serves as negative control.
干预措施: CD10367 solution placebo - Non-desquamated zone (Drug)
Betneval ointment - Non-desquamated zone
This comparator containing Betamethasone valerate 0.1% serves as positive control.
干预措施: Betneval ointment - Non-desquamated zone (Drug)
CD10367 solution placebo - Desquamated zone
干预措施: CD10367 solution placebo - Desquamated zone (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
时间窗: Day 1 to Day 19
The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.
次要结局
- Area Under the Curve (AUC) of Individual Clinical Scores(Day 1 to Day 19)
- Total Sum Score (TSS) of Individual Clinical Scores(Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19)
- Percent Change in Total Sum Score (TSS)(Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19)
- Erythema, Scaling and Induration Scores at Each Visit(Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19)
- Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19(Day 1, Day 4, Day 8, Day 11, Day 15, Day 19)
- Number of Participants With Success Rate at Each Visit(Day 4, Day 8, Day 11, Day 15 and Day 19)
- Time to First Success(Day 1 to Day 19)