KCT0003056
Recruiting
未知
?/?a clinical research to evaluate the safety and effectiveness of EBI-H (Auto-derived activated lymphocyte) for subacute above medium severity and chronic atopic dermatitis patients
GNSBIO0 sites23 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the skin and subcutaneous tissue
- Sponsor
- GNSBIO
- Enrollment
- 23
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) A person under the age of 65 and above the age of 19 years old
- •2\) The proper atopic dermatitis patients according to Hanifin and Rajka diagnostic criteria
- •3\) The subacute and chronic atopic dermatitis patients with atopic dermatitis symptoms that have lasted for more than 6 months at least
- •4\) The subacute above medium severity atopic dermatitis patients (EASI score over 7 points)
- •5\) The specific patients who have not been improved through the general treatment or can not use the pre\-developed medicine because of concern about potential side\-effect
- •6\) A fertile woman who is negative in the pregnancy test and agrees to use the permitted manner of contraception during clinical research
- •7\) A patient who has voluntarily agreed to participate in this clinical research with written consent
Exclusion Criteria
- •1\) A patient who have other uncontrolled diseases including infection above medium severity and bleeding
- •2\) A person who has positive in HBV, HCV, HIV and VDRL
- •3\) A patient whose blood pressure cannot be controlled under SBP 140mmHg or DBP 90mmHg with injecting antihypertensive drug, during screening
- •4\) An uncontrolled patient with diabetes whose HbA1c values is over 8\.0 during screening
- •5\) An asthmatic patient who needs high concentration of inhaled steroids with 2nd modifier or systemic steroid therapy or uncontrolled patient with those treatment
- •6\) A patient who has skin autoimmune disease including psoriasis and systemic autoimmune diseases (Erythema lupus, rheumatism arthritis, severe muscle failure, etc)
- •7\) A person who uses systemic adrenocortical hormone drug, systemic immune suppressor/immune modulator, high potency topical adrenocortical hormone drug (WHO Group I\~III), topical immune modulator and biological drug within 4 weeks before screening
- •8\) A patient who took topical adrenocortical hormone drug (WHO Group IV, V), systemic photochemotherapy and systemic antibiotic within 2 weeks before screening
- •9\) A patient who took antihistamine through oral or injection methods within a week before participating in the clinical research
- •10\) A patient who have taken a prohibited combinatory drug or have to take a prohibited combinatory drug during clinical research
Outcomes
Primary Outcomes
Not specified
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