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This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. AEs/SAEs, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The last estimation of variable scores will occur for all subjects.
This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. During these visits study drug will be administered at the site, new AEs/SAEs as well as follow-up for AEs and SAEs that have not been resolved will be recorded, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The study includes collection of cytokines samples. The end-of-treatment visit and the last estimation of variable scores will occur at week 13 (visit 5) for all subjects. The final visit will be at week 15 (visit 6). Subjects will be encouraged to complete all planned visits regardless of their adherence to study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antroquinonol 100 mg PO QD | Experimental | Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol,once a day. |
|
| Antroquinonol 50 mg PO QD | Experimental | Antroquinonol (Hocena) 50mg/capsule. 1 capsules antroquinonol and 1 capsule placebo, once a day. |
|
| Placebo | Placebo Comparator | Placebo capsule, 2 capsules placebo, once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antroquinonol | Drug | Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EASI value | Eczema Area and Severity Index: Each body region has potentially 100% involvement. Using the table below, give each respective body region a score of between 0 and 6 based on the percentage involvement. Precise measurements are not required. % involvement 0 1-9% 10 - 29% 30 - 49% 50 - 69% 70 - 89% 90 - 100% Region score 0 1 2 3 4 5 6 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD | Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease | 12 weeks |
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Inclusion Criteria:
Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria)
Patients with body weight ≥ 25 kg and ≤ 120 kg, singing informed consent
To be eligible to participate, patients were required to havea.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Chung Wei, MD | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taiwan |
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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 |
|---|---|
| C545357 | antroquinonol |
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This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis. Subjects with diagnosis of atopic dermatitis, using the Hanifin and Rajka Diagnostic Criteria, who meet inclusion/exclusion criteria will be randomized into 3 groups:
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| Placebo | Other | The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |