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Potency of Topical Corticosteroids in Combination Preparations

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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

Tracking Information
First Submitted Date  ICMJE July 21, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date July 31, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potency of Topical Corticosteroids in Combination Preparations
Official Title  ICMJE Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
double-blind controlled comparative study
Primary Purpose: Other
Condition  ICMJE Skin Toxicity
Intervention  ICMJE Combination Product: Combination topical corticosteroid
Comparison of a vasoconstriction index between the 2 study arms
Study Arms  ICMJE
  • 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

    Intervention: Combination Product: Combination topical corticosteroid
  • 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

    Intervention: Combination Product: Combination topical corticosteroid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03606954
Other Study ID Numbers  ICMJE 0316-17-SOR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alex Zvulunov, Ben-Gurion University of the Negev
Study Sponsor  ICMJE Ben-Gurion University of the Negev
Collaborators  ICMJE Soroka University Medical Center
Investigators  ICMJE
Principal Investigator: Raed Khoury, MD Soroka University Medical Center & Ben Gurion University
PRS Account Ben-Gurion University of the Negev
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP