Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Launched by EHL BIO CO., LTD. · Oct 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called ADSTEM Inj. for patients with moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. The goal is to see how safe and effective this treatment is compared to a placebo (a substance with no therapeutic effect). The study is currently active but not recruiting new participants, and it is open to both men and women aged 19 to 70 who have been experiencing symptoms of atopic dermatitis for at least six months. To qualify, participants must have a certain level of severity in their condition, as indicated by specific scoring systems.

If someone is eligible and chooses to participate, they can expect to receive either the ADSTEM treatment or the placebo during the trial. It's important for potential participants to know that they should not have had any recent severe infections or certain underlying health conditions that could interfere with the study. Additionally, participants must agree to use contraception if they are of childbearing age. Overall, this trial aims to provide insights into a new treatment option for people struggling with this challenging skin condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 1. SCORAD score ≥ 20points
• • 2. EASI score ≥ 12points
• • 3. 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
• Exclusion Criteria:
• • Patients with systemic infection symptoms at the time of clinical trials
• • Patients with HIV, HBV, HCV, Syphilis test positive
• • Patients with uncontrolled asthma disease at the time of clinical trial participation
• • Patients who were considered inevitable to receive the medication from 1 month prior to administration of the clinical trial drug to visit 6 such as Immune function modifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topical steroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medication that are thought to affect other immune functions (such as immunoglobulin therapy like dupilumab, tralloquinap and desensitization therapy, etc.)
• • Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who do not use available contraceptive methods (women of childbearing age must be negative in screening pregnancy test)
• • If patients are the male subject, Those who do not agree to have a contraception during the clinical trial (If the male subject or female partner is infertile, the above-mentioned contravention method is unnecessary)
• • Patients participating in other clinical trials or participating in other clinical trials within the last 30 days
• • Patients who have experienced significant adverse events during treatment with stem cell therapies
• • Patients with stem cell therapy doses or history of participating in clinical trials
• • Patients with a history of hypersensitivity to antibiotics and antifungal agents used in the manufacture of medicines for clinical trials
• • Patients with renal dysfunction whose creatinine level is more than twice the normal upper limit in the screening test
• • Patients with hepatic dysfunction whose AST (Aspartate Amino Transaminase) and ALT (Alanine Amino Transaminase) levels are more than three times the normal upper limit
• • Patients who are not suitable for this clinical trial under the judgment of the other examiners