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The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Test product that contains the active pharmaceutical ingredient |
|
| Reference | Active Comparator | Reference product that contains active pharmaceutical ingredient |
|
| Vehicle | Placebo Comparator | Placebo that contains no active pharmaceutical ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0416 | Drug | Topical 0416 test product applied twice daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA). | 2 weeks |
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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 |
|---|---|---|---|---|---|---|
| Fougera Pharmaceuticals Inc. | Melville | New York | 11747 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks |
| FG001 | Reference | Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks. |
| FG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks |
| BG001 | Reference | Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | Number | participants | 2 weeks |
|
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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 | Test | Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Irritation | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela C. Kaplan | Fougera Pharmaceuticals Inc | 631-659-2256 | angela.kaplan@sandoz.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Vehicle of 0416 test product |
| Drug |
Vehicle of 0416 test product applied twice daily for 2 weeks |
|
| tacrolimus ointment 0.1% | Drug | Reference Product for 0416 test product. Apply twice daily for 2 weeks. |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| BG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA). | 2 weeks |
| 0 |
| 269 |
| 6 |
| 269 |
| EG001 | Reference | Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks. | 0 | 260 | 15 | 260 |
| EG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks | 0 | 264 | 8 | 264 |
| Application Site Pruritus | General disorders |
|
| Atopic Dermatitis | Skin and subcutaneous tissue disorders |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |