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The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pandel Cream 0.1% | Experimental | Pandel Cream 0.1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandel Cream 0.1% | Drug | A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-injection Serum Cortisol Level | The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22. | 22 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-injection Serum Cortisol Levels | The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22. | 22 Days |
| and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela C Kaplan | Fougera Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christopher Huerter, MD | Omaha | Nebraska | 68130 | United States | ||
| Oswald Mikell, MD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pandel Cream 0.1% | Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pandel Cream 0.1% | Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Post-injection Serum Cortisol Level | The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22. | 15 subjects represents the subgroup utilized for the analysis of this endpoint. | Posted | Number | participants | 22 Days |
|
|
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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 | Pandel Cream 0.1% | Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela C. Kaplan, Associate Director Clinical Development | Fougera Pharmaceuticals Inc. | 631-659-2256 | angela.kaplan@sandoz.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
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| 22 days |
| Hilton Head Island |
| South Carolina |
| 29926 |
| United States |
| Michael Gold, MD | Nashville | Tennessee | 37215 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Pre-injection Serum Cortisol Levels | The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22. | 15 subjects represents the subgroup utilized for the analysis of this endpoint. | Posted | Number | participants | 22 Days |
|
|
|
| Secondary | and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. | 15 subjects represents the subgroup utilized for the analysis of this endpoint. | Posted | Number | participants | 22 days |
|
|
|
| 0 |
| 19 |
| 7 |
| 19 |
| NASOPHARYNGITIS | Infections and infestations |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders |
|
| HEADACHE | Nervous system disorders |
|
| RASH | Skin and subcutaneous tissue disorders |
|
| APPLICATION SITE IRRITATION | Skin and subcutaneous tissue disorders |
|
| EAR INFECTION | Infections and infestations |
|
| ANXIETY | Psychiatric disorders |
|
| PRURITUS | Skin and subcutaneous tissue disorders |
|
| EXOSTOSIS | Musculoskeletal and connective tissue disorders |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders |
|
| DIZZINESS | Nervous system disorders |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders |
|
| OCCULT BLOOD | Investigations |
|
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| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |