Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Soroka University Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination topical corticosteroid | Active Comparator | 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 |
|
| Non-combination topical corticosteroid | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination topical corticosteroid | Combination Product | Comparison of a vasoconstriction index between the 2 study arms |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raed Khoury, MD | Contact | 0507905159 | raedkhoury1@hotmail.com | |
| Alex Zvulunov, MD | Contact | azvulun@bgu.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Raed Khoury, MD | Soroka University Medical Center & Ben Gurion University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
double-blind controlled comparative study