Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|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.
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.
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.
|Countries||Georgia, Poland, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Halobetasol Propionate Foam
2 weeks of application, 2 times daily
Drug: - Halobetasol Topical Foam
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.