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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Halobetasol Propionate Foam | Experimental | 2 weeks of application, 2 times daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halobetasol Topical Foam | Drug | Foam |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test | 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 | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Piacquadio, MD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 2 | Hialeah | Florida | 33012 | United States | ||
| Investigative Site 1 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Halobetasol Propionate Foam, 0.05% | 24 subjects with stable plaque psoriasis on at least 10% body surface area (BSA) (excluding: face, scalp, groin, axillae, and other intertriginous areas), who fulfilled the inclusion/exclusion criteria were enrolled at multiple study sites in the US and Europe. All subjects were to have a Cosyntropin Stimulation Test (CST) to assess their hypothalamic pituitary adrenal (HPA) axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study should have been timed such that the Screening CST was performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function were eligible to participate in the study. Subjects were instructed to apply Halobetasol Propionate (HBP) Foam, 0.05% to all psoriasis plaques identified at Visit 2/Baseline twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verified the subject's psoriasis had cleared. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2019 |
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| Saint Joseph |
| Missouri |
| 64506 |
| United States |
| Investigative Site 9 | Batumi | Georgia |
| Investigative Site 10 | Tbilisi | 0114 | Georgia |
| Investigative Site 11 | Tbilisi | 0177 | Georgia |
| Investigative Site 3 | Krakow | Poland |
| Investigative Site 5 | Tarnów | Poland |
| Investigative Site 4 | Warsaw | Poland |
| Investigative Site 8 | Rivne | Ukraine |
| Investigative Site 6 | Uzhhorod | Ukraine |
| Investigative Site 7 | Zaporizhzhya | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Halobetasol Propionate Foam | Open label evaluation all participants received Halobetasol Propionate Foam, 0.05% 2 times daily for 2 weeks of application in subjects 12-17 years of age |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test | 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). | Evaluable subjects | Posted | Count of Participants | Participants | Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days |
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| Primary | Plasma Concentration of HBP at Screening, Day 8 and Day 15 | 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. | Pharmacokinetic Population | Posted | Count of Participants | Participants | 15 days |
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Collected at study visits, days 1, 8, and 15.
In accordance with standard MedDRA reporting requirements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Halobetasol Propionate Foam, 0.05% | 24 subjects with stable plaque psoriasis on at least 10% BSA (excluding: face, scalp, groin, axillae, and other intertriginous areas), who fulfilled the inclusion/exclusion criteria were enrolled at multiple study sites in the US and Europe. All subjects were to have a Cosyntropin Stimulation Test (CST) to assess their HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study should have been timed such that the Screening CST was performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function were eligible to participate in the study. Subjects were instructed to apply HBP Foam, 0.05% to all psoriasis plaques identified at Visit 2/Baseline twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verified the subject's psoriasis had cleared. | 0 | 24 | 0 | 24 | 7 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local skin reactions | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Telangiectasia and skin atrophy |
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| ACTH Stimulation Test Abnormal | Endocrine disorders | MedDRA (10.0) | Systematic Assessment | ACTH Stimulation Test Abnormal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Ann McDowell, PharmD - Director of Medical Affairs | Mayne Pharma | 4124776681 | leeann.mcdowell@maynepharma.com |
| Dec 20, 2022 |
| Prot_SAP_000.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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