- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992261
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 4 (for US site only, Phase 2 for non-US sites), open label, multicenter study of halobetasol propionate (HBP) Foam, 0.05% in male and female subjects who are 12 to less than 18 years of age with stable plaque psoriasis. Twenty-four subjects with stable plaque psoriasis on at least 10% of their body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites in the US and Europe. All subjects are to have a Cosyntropin Stimulation Test (CST) to assess their (hypothalmic pituitary adrenal) HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study will be timed such that the Screening CST is performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function will be eligible to participate in the study.
The primary objective of the study is to assess safety, not efficacy. Safety will be determined by assessing the adrenal suppression potential and the PK properties of HBP Foam, 0.05% applied twice daily in male and female subjects who were 12 to less than 18 years of age with stable plaque psoriasis.
Other safety endpoints include plasma levels of HBP. Trough HBP concentrations in plasma on day 8 and 15 will be calculated and summarized. Efficacy will also be noted utilizing the Investigator's Global Assessment (IGA) scale and percent BSA treated and affected with disease to assess and document any changes observed with regard to IGA and percent BSA.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Batumi, Georgia
- Investigative Site 9
-
Tbilisi, Georgia, 0114
- Investigative Site 10
-
Tbilisi, Georgia, 0177
- Investigative Site 11
-
-
-
-
-
Krakow, Poland
- Investigative Site 3
-
Tarnów, Poland
- Investigative Site 5
-
Warszawa, Poland
- Investigative Site 4
-
-
-
-
-
Rivne, Ukraine
- Investigative Site 8
-
Uzhhorod, Ukraine
- Investigative Site 6
-
Zaporizhzhya, Ukraine
- Investigative Site 7
-
-
-
-
Florida
-
Hialeah, Florida, United States, 33012
- Investigative Site 2
-
-
Missouri
-
Saint Joseph, Missouri, United States, 64506
- Investigative Site 1
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Halobetasol Propionate Foam
2 weeks of application, 2 times daily
|
Foam
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test
Time Frame: Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days
|
A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL. HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS). |
Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days
|
Plasma Concentration of HBP at Screening, Day 8 and Day 15
Time Frame: 15 days
|
Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum.
|
15 days
|
Collaborators and Investigators
Investigators
- Study Director: Daniel J Piacquadio, MD, Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122-0551-209
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Biocon Biologics Inc.MEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on Halobetasol Topical Foam
-
Skin Sciences, PLLCUnknownPlaque PsoriasisUnited States
-
Sun Pharmaceutical Industries LimitedNovum Pharmaceutical Research ServicesTerminated
-
Sun Pharmaceutical Industries LimitedTerminatedPlaque PsoriasisUnited States
-
Johnson & Johnson Healthcare Products Division...Johnson & Johnson Consumer and Personal Products WorldwideCompletedAndrogenetic AlopeciaUnited States, United Kingdom, France, Germany
-
Sun Pharmaceutical Industries LimitedNovum Pharmaceutical Research ServicesWithdrawn
-
Icahn School of Medicine at Mount SinaiCompletedPsoriasis | Plaque PsoriasisUnited States
-
Applied Biology, Inc.CompletedAndrogenetic AlopeciaUnited States, Australia, India, Italy
-
Applied Biology, Inc.CompletedAlopecia | Female Pattern Hair LossUnited States, Australia, India, Italy
-
Minia UniversityActive, not recruiting
-
Vyne Therapeutics Inc.Completed