To evaluate the efficacy and safety of oral administration of dose-dependent EC-18 for 16 weeks in patients with moderate to severe atopic dermatitis
This study will utilize a randomized, double blind, placebo-controlled, parallel-group, multi-Center design. The Experimental group 1 will receive 1000mg of EC-18\[2 capsules of EC-18 500mg, 2 capsules of placebo\]. The experimental group 2 will receive 2000mg of EC-18 \[4 capsules of EC-18\]. The placebo group will receive 4 capsules of placebo. The time frame of this clinical trial will consist 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
oral administration, QD
oral administration, QD
Change in EASI score at 16 weeks compared to baseline
Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities) Score range: \[0=none \~ 72=very severe\]
Time frame: Baseline, week 16
Change in EASI score at 4, 8, and 12 weeks compared to baseline.
Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities) Score range: \[0=none \~ 72=very severe\]
Time frame: Baseline, week 4, 8, 12
Percentage change in EASI score at 4, 8, 12, and 16 weeks compared to baseline
Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities) Score range: \[0=none \~ 72=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Proportion of subjects achieving EASI-50, EASI-75, and EASI-90 at 4, 8, 12, and 16 weeks compared to baseline.
Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities) Score range: \[0=none \~ 72=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Change in IGA score at 4, 8, 12, and 16 weeks compared to baseline.
Investigator's Global Assessment(IGA) score: \[0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe\]
Time frame: Baseline, week 4, 8, 12, 16
Proportion of subjects with an IGA score of 0 or 1 and at least a 2-point reduction in IGA score at 4, 8, 12, and 16 weeks compared to baseline.
Investigator's Global Assessment(IGA) score: \[0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe\]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, week 4, 8, 12, 16
Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline. Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline. Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline.
Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Percentage change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline.
Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Proportion of subjects with a pruritus NRS score reduction of 4 points or more at 4, 8, 12, and 16 weeks compared to baseline.
Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Change in sleep disturbance NRS score at 4, 8, 12, and 16 weeks compared to baseline.
Sleep Disturbance Numerical Rating Scale(NRS): The scale of perceived sleep disturbance from \[0=none to 10=very severe\]
Time frame: Baseline, week 4, 8, 12, 16
Frequency and duration of application of the rescue medication (tacrolimus ointment).
Time frame: week 4 ~ week 16