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Potency of Topical Corticosteroids in Combination Preparations

NCT ID: NCT03606954

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Skin Toxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
double-blind controlled comparative study

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Combination topical corticosteroid

Intervention Type COMBINATION_PRODUCT

Comparison of a vasoconstriction index between the 2 study arms

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

Group Type ACTIVE_COMPARATOR

Combination topical corticosteroid

Intervention Type COMBINATION_PRODUCT

Comparison of a vasoconstriction index between the 2 study arms

Interventions

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Combination topical corticosteroid

Comparison of a vasoconstriction index between the 2 study arms

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role lead

Responsible Party

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Alex Zvulunov

Head, Department of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raed Khoury, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center & Ben Gurion University

Central Contacts

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Raed Khoury, MD

Role: CONTACT

Phone: 0507905159

Email: [email protected]

Alex Zvulunov, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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0316-17-SOR

Identifier Type: -

Identifier Source: org_study_id