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The aim of this trial is to assess the efficacy of 0417 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 4 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 the active pharmaceutical ingredient |
|
| Vehicle | Placebo Comparator | Placebo that contains no active pharmaceutical ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0417 | Drug | Topical 0417 test product applied twice daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region | Baseline, 4 weeks | |
| The Mean Change From Baseline in Pruritus | Baseline, 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 0.03% test product applied twice daily for 4 weeks |
| FG001 | Reference | Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks |
| FG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 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 0.03% test product applied twice daily for 4 weeks |
| BG001 | Reference | Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 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 | 4 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 0.03% test product applied twice daily for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate Influenza | Infections and infestations |
| 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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| ID | Term |
|---|---|
| C000723274 | SIM0417 |
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| Vehicle of 0417 test product |
| Drug |
Vehicle of 0417 test product applied twice daily for 4 weeks |
|
| Tacrolimus Ointment 0.03% | Drug | Reference product for 0417 test product. Apply twice daily for 4 weeks |
|
| The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA) |
| Baseline, 4 weeks |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Administrative |
|
| Adverse Event |
|
| BG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 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 | Baseline, 4 weeks |
| Secondary | The Mean Change From Baseline in Pruritus | Baseline, 4 weeks |
| Secondary | The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA) | Baseline, 4 weeks |
| 1 |
| 302 |
| 17 |
| 302 |
| EG001 | Reference | Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks | 0 | 297 | 12 | 297 |
| EG002 | Vehicle | Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks | 1 | 300 | 20 | 300 |
| Severe Angina Pectoris | Cardiac disorders |
|
| Ovarian Cyst | Reproductive system and breast disorders |
|
| Dermatitis atopic | 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 |