Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
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.
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|Eligible Ages||12 Years - 17 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Mayne Pharma International Pty Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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