Potency of Topical Corticosteroids in Combination Preparations

NCT03606954 | Unknown Phase 4

• 1 other identifier: 0316-17-SOR
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Combination Product: Combination topical corticosteroid

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

Combination Product: Combination topical corticosteroid

Interventions

Combination topical corticosteroid COMBINATION_PRODUCT

Comparison of a vasoconstriction index between the 2 study arms

Combination topical corticosteroid; Non-combination topical corticosteroid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No prior history of internal diseases that required vaccine-suppressing treatments
• Absence of an active skin disease.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead
• Soroka University Medical Center: collaborator

Study Officials

• Raed Khoury, MD

  Soroka University Medical Center & Ben Gurion University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raed Khoury, MD

CONTACT

0507905159; raedkhoury1@hotmail.com

Alex Zvulunov, MD

CONTACT

azvulun@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind controlled comparative study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Dermatology

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: July 31, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 31, 2018

Record last verified: 2018-07