Study of ADSTEM Injection for Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
286
hAD-MSC 1.0x10\^8 cells
0.9% Normal Saline Inj.
Percentage of participants who achieve a score of 0 or 1 on the validated Investigator's Global Assessment (vIGA) scale at Visit 6, and demonstrate at least a 2-point reduction from baseline(Visit 2)
validated Investigator's Global Assessment \[vIGA\], 0-4, higher scores indicate worse disease severity
Time frame: From baseline to Weeks 16
Change from baseline (Visit 2) in vIGA score
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a vIGA score reduction of 1 point or ≥2 points from baseline (Visit 2)
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a vIGA score of 0 or 1 at Week 24
Time frame: From baseline to Week 24
Percentage of participants with a ≥50% reduction in total EASI score from baseline (Visit 2)
Eczema Area and Severity Index \[EASI\], 0-72, higher scores indicate worse disease severity
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥75% reduction in total EASI score from baseline (Visit 2)
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥90% reduction in total EASI score from baseline (Visit 2)
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in total EASI score
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of participants with a ≥50% reduction in total SCORAD score from baseline (Visit 2)
Scoring Atopic Dermatitis \[SCORAD\], 0-103, higher scores indicate worse disease severity
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥75% reduction in total SCORAD score from baseline (Visit 2)
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in total SCORAD score
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in individual SCORAD item scores
Time frame: From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in DLQI score
Dermatology Life Quality Index \[DLQI\], 0-30, higher scores indicate worse quality of life
Time frame: From baseline to Weeks 8, 16, and 24
Percentage of participants using rescue medication, number of uses, and total amount used
Time frame: From Week -6 (Visit 1) to Weeks 4, 8, 12, 16, 20, and 24