Primary Objective: To evaluate the activity of Antroquinonol in patients with atopic dermatitis. Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with atopic dermatitis. Exploratory Objective: To explore potential relationships between Antroquinonol exposure and safety and efficacy endpoints.
This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with atopic dermatitis. The study is conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval is obtained from the local ethics committee or institutional review board at each study center. All the patients provided written informed consent. 60 patients totally (20 patients per arm) with atopic dermatitis will receive Antroquinonol or placebo. A patient will have received at one dose of Antroquinonol or placebo with tropical urea ointment and have three baseline scores assessment (see Statistical Methods). Enrollment will continue until the target number of evaluable patients has been enrolled. Written informed consent must be obtained from all patients before initiating Screening. The Screening period will be up to 14 days in duration (Days -14 to -1). Following completion of all Screening assessments and confirmation of eligibility criteria, patients will receive Antroquinonol 50mg, 100mg or placebo per day (QD) on Day 0 for 12 weeks or until documented evidence of unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. The time of study drug administration should be recorded in the patient diary. Patients will attend study visits on Days 0, 28, 56 and 84. The following procedures will be performed according to the schedule of assessments: physical examination, vital signs, performance status, clinical laboratory tests, adverse events (AEs), concomitant medication and patient compliance. Scores assessments will be performed at Screening, Day 28, Day 56 and Day 84 including EASI score, SCORAD, sIGA score, BSA affected by atopic dermatitis and pruritus verbal rating scale. The primary endpoint is the percentage improvement between baseline and week 12 in Eczema Area and Severity Index (EASI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
14
patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
patients will receive placebo per day (QD) on Day 1 for 12 weeks
Chung Shan Medical University Hospital
Taichung, Taiwan
Eczema Area and Severity Index (EASI)
The percentage improvement between week 0(baseline) and week 12 in Eczema Area and Severity Index (EASI)
Time frame: week 0(baseline) and week12
Eczema Area and Severity Index (EASI) at each time point
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the EASI score
Time frame: week 0(baseline), week 4, week8 and week12
Scoring Atopic Dermatitis (SCORAD)
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Scoring Atopic Dermatitis (SCORAD), which ranges from 0 to 103, with higher scores indicating more severe disease
Time frame: week 0(baseline), week 4, week8 and week12
static Investigator's Global Assessment (sIGA)
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the sIGA score
Time frame: week 0(baseline), week 4, week8 and week12
Body-surface area affected by atopic dermatitis
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Body-surface area affected by atopic dermatitis
Time frame: week 0(baseline), week 4, week8 and week12
Pruritus verbal rating scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Pruritus verbal rating scale, which describes pruritus intensity from 0 (none) to 10(very severe) daily
Time frame: week 0(baseline), week 4, week8 and week12
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Sleep-disturbance visual-analogue scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the Sleep-disturbance visual-analogue scale, which ranges from 0 (no sleep disturbance) to 10 (inability to sleep at all) daily
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the pruritus visual-analogue scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the pruritus visual-analogue scale
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the EASI
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the EASI
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with 25%, 50%, and 75% improvement in scores on the SCORAD
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with 25%, 50%, and 75% improvement in scores on the SCORAD
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the sIGA
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with an improvement of at least 2 points on the sIGA
Time frame: week 0(baseline), week 4, week8 and week12
The proportion of patients with an improvement of at least 2 points on the pruritus verbal rating scale
Secondary endpoints at week 12 and at each time point (weeks 4, 8 and 12) included improvement from baseline in the proportion of patients with an improvement of at least 2 points on the pruritus verbal rating scale
Time frame: week 0(baseline), week 4, week8 and week12