Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis

• Status: Completed
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayne Pharma International Pty Ltd
• Treatments: Clobetasol; Halobetasol

Criteria

Key Inclusion Criteria:

• Subject is male or non-pregnant female and is 12 to less than 18 years of age

• Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing

• Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% Body Surface Area (BSA)

• Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit

Key Exclusion Criteria:

• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis

• Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

• Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation

• Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation

• Subject is pregnant, lactating, or is planning to become pregnant during the study

• Subject is currently enrolled in an investigational drug or device study