Potency of Topical Corticosteroids in Combination Preparations

Skin Toxicity Clinical Trial

Official title:

Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03606954
• Other study ID #: 0316-17-SOR
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2018
• Est. completion date: April 2019

Study information

• Verified date: July 2018
• Source: Ben-Gurion University of the Negev
• Contact: Raed Khoury, MD
• Phone: 0507905159
• Email: raedkhoury1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Toxicity

Intervention

Combination Product:
• Combination topical corticosteroid
Comparison of a vasoconstriction index between the 2 study arms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev	Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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