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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003684-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD 1 | Experimental | AM1030-CREAM |
|
| SAD 2 | Experimental | AM1030-CREAM |
|
| SAD 3 | Experimental | AM1030-CREAM |
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| MAD 1 | Experimental | AM1030-CREAM |
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| MAD 2 | Experimental | AM1030-CREAM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AM1030-CREAM or placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events as a measure of Safety | Day 1-15 |
| Local Tolerability: Change in Erythema (Likert scale 0-4) | Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability | Day 1-15 |
| Local Tolerability: Change in Oedema (Likert scale 0-3) | Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability | Day 1-15 |
| Local Tolerability: Change in Burning (Likert scale 0-3) | Change in Burning (Likert scale 0-3) as a measure of Local Tolerability | Day 1-15 |
| Local Tolerability: Change in Prutitus (VAS) | Change in Prutitus (VAS) as a measure of Local Tolerability | Day 1-15 |
| Vital Signs | Change in blood pressure as a measure of Safety | Day 1-15 |
| Vital Signs | Change in pulse rate as a measure of Safety | Day 1-15 |
| Vital Signs | Change in body temperature as a measure of Safety | Day 1-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F | Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F | Profil Day 1-15 |
| Pruritus on a Visual Analog Scale | Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU | Leeds | LS2 9LH | United Kingdom | |||
| CRLCRU Royal Liverpool University Hospital |
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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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| ECG | Change in ECG as a measure of Safety | Day 1-15 |
| Physical Examination | Any abnormal observations from Physical Examination as a measure of Safety | Day 1-15 |
| Day 1-15 |
| Erythema on a Likert scale | Erythema (Likert Scale 0-4) as a measure of Efficacy | Day 1-15 |
| Modified Eczema Area and Severity Index (mEASI) | mEASI (Composite score 0-64.8) as a measure of Efficay | Day 1-15 |
| Liverpool |
| L7 8XP |
| United Kingdom |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |