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

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ClinicalTrials.gov Identifier: NCT03992261
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mayne Pharma International Pty Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Halobetasol Topical Foam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Foam, 0.05% in Subjects 12 to Less Than 18 Years of Age With Plaque Psoriasis Receiving Two Weeks of Treatment
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Halobetasol Propionate Foam
2 weeks of application, 2 times daily
Drug: Halobetasol Topical Foam
Foam
Other Name: HBP Foam




Primary Outcome Measures :
  1. The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test [ Time Frame: 28 days ]
    A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is less than or equal to 18.0 mcg/100 mL.

  2. The pharmacokinetic properties of HBP foam [ Time Frame: 14 days ]
    Blood samples will be drawn to assess the concentration of HBP absorbed into the body.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992261


Contacts
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Contact: Alicia Alton 252-945-0183 alicia.alton@maynepharma.com

Locations
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United States, Florida
Investigative Site 2 Recruiting
Hialeah, Florida, United States, 33012
Contact: Alicia Alton       alicia.alton@maynepharma.com   
United States, Missouri
Investigative Site 1 Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Alicia Alton       alicia.alton@maynepharma.com   
Georgia
Investigative Site 11 Recruiting
Batumi, Georgia
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 12 Recruiting
Tbilisi, Georgia
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 13 Recruiting
Tbilisi, Georgia
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Poland
Investigative Site 3 Recruiting
Krakow, Poland
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 5 Recruiting
Tarnów, Poland
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 4 Recruiting
Warszawa, Poland
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Ukraine
Investigative Site 9 Not yet recruiting
Dnipro, Ukraine
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 10 Not yet recruiting
Kyiv, Ukraine
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 8 Recruiting
Rivne, Ukraine
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 6 Recruiting
Uzhhorod, Ukraine
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Investigative Site 7 Recruiting
Zaporizhzhya, Ukraine
Contact: Alicia Alton       Alicia.Alton@maynepharma.com   
Sponsors and Collaborators
Mayne Pharma International Pty Ltd

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Responsible Party: Mayne Pharma International Pty Ltd
ClinicalTrials.gov Identifier: NCT03992261     History of Changes
Other Study ID Numbers: 122-0551-209
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Halobetasol
Physiological Effects of Drugs
Vasoconstrictor Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists