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This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns under maximal use conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB-03-01 cream, 1% | Experimental | Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cortexolone 17α-propionate | Drug | CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HPA Axis Response as Measured by CST | Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14. | Pre- and Post-CST on Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Trough Plasma Concentrations | Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14. | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R&D Department | Cassiopea SpA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 103 | Fort Smith | Arkansas | 72916 | United States | ||
| Site 101 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CB-03-01 Cream, 1% | Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder. |
| 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 | Yes | No | No | Study Protocol | Feb 18, 2016 | Sep 23, 2020 |
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| San Diego |
| California |
| 92037 |
| United States |
| Site 102 | Houston | Texas | 77030 | United States |
| Site 4814 | Częstochowa | Poland |
| Site 4811 | Katowice | Poland |
| Site 4813 | Krakow | Poland |
| Site 4815 | Krakow | Poland |
| Site 4816 | Rzeszów | Poland |
| Site 4812 | Szczecin | Poland |
| Site 4817 | Tarnów | Poland |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population, defined as all enrolled subjects who were dispensed and applied at least one dose of the test article. All enrolled subjects were included in the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | CB-03-01 Cream, 1% | Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder. |
| 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, Continuous | Mean | Standard Deviation | years |
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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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| Baseline HPA Axis Response | Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). Hypothalamic-pituitary-adrenal (HPA) axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14. | Evaluable Population, defined as all subjects in the Safety population who had evaluable cortisol assay data. | Mean | Standard Deviation | mcg/dL |
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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 | Change in HPA Axis Response as Measured by CST | Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14. | Evaluable population, defined as all subjects in the safety population who had evaluable cortisol assay data. | Posted | Mean | Standard Deviation | mcg/dL | Pre- and Post-CST on Day 14 |
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| Secondary | Evaluate Trough Plasma Concentrations | Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14. | The pharmacokinetic (PK) population included those subjects in the Safety population who had at least an 80% dose compliance based on number of applications, had at least one post-baseline PK blood draw within ±2 days of the scheduled visit at Days 7 and 14, and did not have any significant protocol deviations. | Posted | Mean | Standard Deviation | ng/mL | 14 Days |
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14 Days or up to 42 days for those with laboratory evidence of adrenal suppression (i.e., post-stimulation serum cortisol level ≤18 μg/dL at Day 14).
Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs. Subjects with laboratory evidence of adrenal suppression at Day 14 were required to be re-tested 4 weeks later (Day 42); all four subjects returned to normal HPA function.
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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 | CB-03-01 Cream, 1% | Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days cortexolone 17α-propionate (USAN/INN: clasocoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder. | 0 | 27 | 0 | 27 | 5 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| ACTH stimulation test abnormal | Investigations | MedDRA version 18.1 | Systematic Assessment | Adrenocorticotropic Hormone (ACTH) stimulation testing is conducted by the Cosyntropin Stimulation Test. |
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The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cassiopea R&D | Cassiopea, SpA | +39 02 868 911 24 | r&d@cassiopea.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2017 | Sep 23, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C496269 | Clascoterone |
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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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| Cortisol Level (Post-CST) |
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