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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Chung Shan Medical University Hospital
Taichung, Taiwan
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
Time frame: 12 weeks
SCORAD
Scoring Atopic Dermatitis which ranges from 0 to 103, with higher scores indicating more severe disease
Time frame: 12 weeks
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