A Phase 1 Clinical Trial to Evaluate the Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Positive skin reaction at 24 hours or 48 hours after irradiation
研究概览
简要总结
This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 18-64 years (inclusive).
- •Fitzpatrick skin type of I, II, or III.
排除标准
- •Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes or dense body hair in the range of the test fields.
- •Any history of or presence of cancerous or precancerous skin lesions.
- •Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
- •Known disease that can be induced by ultraviolet (UV) light.
- •Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until end of trial.
- •Use of drugs which might cause photobiologic or phototoxic reactions within 4 weeks before randomisation until end of trial.
- •Foreseeable intensive UV light exposure (solar or artificial) to test fields within 4 weeks before randomisation until end of trial.
研究组 & 干预措施
Delgocitinib cream 1 mg/g
Single topical occlusive administration
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 3 mg/g
Single topical occlusive administration
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 8 mg/g
Single topical occlusive administration
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 20 mg/g
Single topical occlusive administration
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream vehicle
Single topical occlusive administration
干预措施: Delgocitinib cream vehicle (Drug)
结局指标
主要结局
Positive skin reaction at 24 hours or 48 hours after irradiation
时间窗: Up to 48 hours after irradiation
A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: * 0 No reaction * 1 Erythema * 2 Erythema with dermal infiltrate * 3 Erythema with papulovesicles * 4 Erythema with blisters, erosions
次要结局
- Positive skin reaction at 24 hours after irradiation(24 hours after irradiation)
- Positive skin reaction at 48 hours after irradiation(48 hours after irradiation)