A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis. The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.
• At the time of visit 1, only men and women aged between 19 and 70
• Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria
• Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months
• Patients with moderate to severe atopic dermatitis who meet all of the following criteria
‣ SCORAD score ≥ 20points
⁃ EASI score ≥ 12points
⁃ BSA ≥ 10%
• Patients with inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks prior to study initiation, or those who are unable to administer topical atopic dermatitis treatment due to safety reasons
• Patients who voluntarily agreed in writing to participate in this clinical trial