Potency of Topical Corticosteroids in Combination Preparations

Phase 4

• Conditions: Skin Toxicity
• Interventions: Combination Product: Combination topical corticosteroid

• Registration Number: NCT03606954
• Lead Sponsor: Ben-Gurion University of the Negev

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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-21
• Study First Submitted QC: 2018-07-29
• Last Update Submitted: 2018-07-29
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31
• Study Start: 2018-11
• Primary Completion: 2019-03
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination topical corticosteroid	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
Non-combination topical corticosteroid	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

Primary Outcome Measures

Name	Time	Method
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.