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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

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.

Trial ID:
NCT03992261

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.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Mayne Pharma International Pty Ltd

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigative Site 1, Saint Joseph, Missouri

Status

Recruiting

Address

Investigative Site 1

Saint Joseph, Missouri, 64506

Site Contact

Alicia Alton

[email protected]

252-945-0183

Investigative site 02, Hialeah, Florida

Status

Recruiting

Address

Investigative site 02

Hialeah, Florida, 33012

Site Contact

Alicia Alton

[email protected]

252-945-0183

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