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Potency of Topical Corticosteroids in Combination Preparations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606954
Recruitment Status : Unknown
Verified July 2018 by Alex Zvulunov, Ben-Gurion University of the Negev.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Soroka University Medical Center
Information provided by (Responsible Party):
Alex Zvulunov, 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.


Condition or disease Intervention/treatment Phase
Skin Toxicity Combination Product: Combination topical corticosteroid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double-blind controlled comparative study
Primary Purpose: Other
Official Title: Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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




Primary Outcome Measures :
  1. Vasoconstriction Index (VI) measured by Skin Color Reflectometry [ Time Frame: 24 hours ]
    VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606954


Contacts
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Contact: Raed Khoury, MD 0507905159 raedkhoury1@hotmail.com
Contact: Alex Zvulunov, MD azvulun@bgu.ac.il

Sponsors and Collaborators
Ben-Gurion University of the Negev
Soroka University Medical Center
Investigators
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Principal Investigator: Raed Khoury, MD Soroka University Medical Center & Ben Gurion University
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Responsible Party: Alex Zvulunov, Head, Department of Dermatology, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT03606954    
Other Study ID Numbers: 0316-17-SOR
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No