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The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topicort® Topical Spray, 0.25% | Experimental | Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topicort® (desoximetasone) Topical Spray, 0.25% | Drug | Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | The total number of subjects experiencing adverse events. | 28 days |
| Cpre-ss | Concentration prior to dosing at steady state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novum Pharmaceutical Research Services | http://www.novumprs.com/contact | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taro Pharmaceuticals USA Inc. | Hawthorne | New York | 10532 | United States |
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Prior to the Protocol Amendment if a subject was found to have an abnormal adrenal function test after the baseline Cortisol Response test the subject was notified to discontinue the drug and follow up with the Investigator. After the protocol amendment a screening visit was added so that subjects with abnormal tests would not be randomized to study drug.
The first patient enrolled in the study 23 January 2015. The last patient completed the study 22 November 2019. The Patients were enrolled in 3 cohorts. Cohort 1, 12 to 17 years and 11 months, Cohort 2, 6 year to 11 and 11 Months and Cohort 3, 2 years to 5 years and 11 months. In total 129 subjects were enrolled across 7 Investigator sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topicort® Topical Spray, 0.25% | Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topicort® Topical Spray, 0.25% | Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:
| Posted | Count of Participants | Participants | 28 days |
|
For each subject Adverse Events were collected during their 28 day treatment period.
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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 | Topicort® Topical Spray, 0.25% | Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Taro Pharmaceuticals | +1 914-345-9001 | natalie.yantovskiy@taro.com |
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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 | Feb 6, 2020 | Dec 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003899 | Desoximetasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| 28 Days |
| Participants |
|
| Sex: Female, Male | the participants were analyzed in three separate cohorts | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Function | HPA axis suppression was measured in the 100 evaluable subjects. | HPA Axis suppression was measured in the 100 evaluable subjects. | Count of Participants | Participants |
|
| Cohort 3 |
2 to 5 years of age |
|
|
|
| Secondary | Adverse Event | The total number of subjects experiencing adverse events. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Cpre-ss | Concentration prior to dosing at steady state. | PK sampling from was taken from a subset of patients in cohorts 1 and 2 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 28 Days |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003907 | Dexamethasone |
| D013259 | Steroids, Fluorinated |