Skin Toxicity
Conditions
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.
Interventions
COMBINATION_PRODUCTCombination topical corticosteroid
Comparison of a vasoconstriction index between the 2 study arms
Sponsors
Soroka University Medical Center
Ben-Gurion University of the Negev
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blind controlled comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasoconstriction Index (VI) measured by Skin Color Reflectometry | 24 hours | VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs. |
Contacts
Primary ContactRaed Khoury, MD
Backup ContactAlex Zvulunov, MD
Outcome results
None listed