Potency of Topical Corticosteroids in Combination Preparations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers

Conditions
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Skin Toxicity

Intervention / Treatment
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* Combination Product: Combination topical corticosteroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combination topical corticosteroid<br>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 | Combination Product: Combination topical corticosteroid<br>* Comparison of a vasoconstriction index between the 2 study arms<br>|
| Active Comparator: Non-combination topical corticosteroid<br>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 | Combination Product: Combination topical corticosteroid<br>* Comparison of a vasoconstriction index between the 2 study arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoconstriction Index (VI) measured by Skin Color Reflectometry | VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs. | 24 hours |