Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Skin Toxicity
- Sponsor
- Ben-Gurion University of the Negev
- Enrollment
- 20
- Primary Endpoint
- Vasoconstriction Index (VI) measured by Skin Color Reflectometry
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Alex Zvulunov
Head, Department of Dermatology
Ben-Gurion University of the Negev
Eligibility Criteria
Inclusion Criteria
- •No prior history of internal diseases that required vaccine-suppressing treatments
- •Absence of an active skin disease.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Vasoconstriction Index (VI) measured by Skin Color Reflectometry
Time Frame: 24 hours
VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.