Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- Vasoconstriction Index (VI) measured by Skin Color Reflectometry
研究概览
简要总结
Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.
Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids.
详细描述
Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind controlled comparative study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No prior history of internal diseases that required vaccine-suppressing treatments
- •Absence of an active skin disease.
排除标准
- •Treatment with topical corticosteroids in the 4 weeks prior to the study
- •Immune-suppressive treatment in the 4 weeks prior to the study
- •Pregnancy or breast feeding
研究组 & 干预措施
Combination topical corticosteroid
The combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability.
The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale
干预措施: Combination topical corticosteroid (Combination Product)
Non-combination topical corticosteroid
The non-combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability.
The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale
干预措施: Combination topical corticosteroid (Combination Product)
结局指标
主要结局
Vasoconstriction Index (VI) measured by Skin Color Reflectometry
时间窗: 24 hours
VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.
次要结局
未报告次要终点
研究者
Alex Zvulunov
Head, Department of Dermatology
Ben-Gurion University of the Negev