Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
148
Hemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor.
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, China
Ningbo second hospital
Ningbo, Zhejiang, China
The change in the EASI score relative to the baseline.
EASI Clinical Signs Severity Sum Score change from Baseline at Day 29
Time frame: Day 29
The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Time frame: Day 8, Day 15, Day 22, Day 28
The change in the IGA score relative to the baseline.
Change From Baseline in the IGA Clinical Signs Severity Sum Score.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving EASI90, EASI75, EASI50.
EASI Clinical Signs Severity Sum Score ≥50%, 75%, 90% improvement from baseline.
Time frame: Day 8, Day 15, Day 22, Day 28
Absolute change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS).
Range of 0 (No itch) to 10 (Worst imaginable itch)
Time frame: Day 8, Day 15, Day 22, Day 28
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score.
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 8, Day 15, Day 22, Day 28
The percentage of AD invoved BSA (body surface area) change From Baseline.
AD invoved body surface area.
Time frame: Day 8, Day 15, Day 22, Day 28