Potency of Topical Corticosteroids in Combination Preparations

Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: Skin Toxicity
• Intervention / Treatment: Combination product: Combination topical corticosteroid

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Combination product: Combination topical corticosteroid; Comparison of a vasoconstriction index between the 2 study arms
ACTIVE_COMPARATOR: Non-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	Combination product: Combination topical corticosteroid; Comparison of a vasoconstriction index between the 2 study arms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ben-Gurion University of the Negev
• Collaborators: Soroka University Medical Center
• Investigators: Principal Investigator: Raed Khoury, MD, Soroka University Medical Center & Ben Gurion University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: July 21, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 29, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0316-17-SOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No