Potency of Topical Corticosteroids in Combination Preparations

Ben-Gurion University of the Negev

Status and phase: Unknown; Phase 4

Conditions: Skin Toxicity

Treatments: Combination Product: Combination topical corticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT03606954

0316-17-SOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Combination topical corticosteroid

Active Comparator group

Description:

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

Treatment:

Combination Product: Combination topical corticosteroid

Non-combination topical corticosteroid

Active Comparator group

Description:

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

Treatment:

Combination Product: Combination topical corticosteroid