An Open, Uncontrolled Pharmacokinetic Study With a New Topical Combination Gel Containing Triiodothyroacetic Acid (TRIAC) and Dehydroepiandrosterone (DHEA) in Subjects With Skin Atrophy Due to Topical Treatment With Glucocorticoids
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
研究概览
简要总结
An open, uncontrolled pharmacokinetic study with a new topical combination gel containing triiodothyroacetic acid (TRIAC) and dehydroepiandrosterone (DHEA) in subjects with skin atrophy due to topical treatment with glucocorticoids.
详细描述
At the Baseline Visit (Day 1) and after completion of all evaluations, each subject who qualifies for entry will will receive a dose of 0.5 g IMP on the back of a hand affected with skin atrophy.
PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained prior to initiating any study specific procedures
- •Men and women of at least 18 years old
- •Subjects with hand eczema and confirmed skin atrophy on the back of a hand caused by treatment with topical glucocorticoids for at least 6 months
- •Atrophic skin area of approximately 100 cm2 (back of a hand)
- •Females of childbearing potential must have a negative urine pregnancy test result upon entry into the study
- •Females of child-bearing potential may participate only if using reliable means of contraception
排除标准
- •Skin atrophy with open ulcer(s) involved
- •Participation in any other study involving investigational drug(s) within 30 days prior to study entry
- •Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues, DHEA, and testosterone within 3 weeks before entry into the study
- •Known thyroid disease of any type
- •Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other androgen excess syndromes
- •Subjects who have previously participated in this study
研究组 & 干预措施
Open uncontrolled pharmacokinetic study
Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
干预措施: DHEA and TRIAC (Combination Product)
结局指标
主要结局
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
时间窗: 0-72 hours
MS-based method for analysis of DHEA will be used.
Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
时间窗: 0-72 hours
MS-based method for analysis of DHEA-S will be used.
Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
时间窗: 0-72 hours
MS-based method for analysis of TRIAC will be used.
次要结局
未报告次要终点