Atopic Dermatitis Clinical Trial
Official title:
Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.
Status | Completed |
Enrollment | 34 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Of either gender, aged =20 and =60 years - Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria - subacute and chronic Atopic subjects who have Atopic Dermatitis symptoms continually at least 6 months - Subjects with over moderate atopic dermatitis( SCORAD score > 20 ) - Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: - Subjects who have systemic infection at the baseline visit - Subjects who have asthma at the baseline visit - Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit - Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit - Subjects who already took or need to take the medicine which is prohibited to take during the clinical study. - Pregnant, breast-feeding women or women who plan to become pregnant during this study. (Females of Childbearing Potential must have a negative urine pregnancy test at Screening and Baseline) - Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days - Creatinine value = 2 Upper limit of the normal range at screening test - AST/ALT value = 2 Upper limit of the normal range at screening test - Any other condition which the investigator judges would make patient unsuitable for study participation |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Catholic Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kang Stem Biotech Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value | 4 weeks follow-up after treatment | No | |
Secondary | SCORAD Total Score | 4 weeks follow-up after treatment | No | |
Secondary | the degrees of disease | 4 weeks follow-up after treatment | No | |
Secondary | Valuation of IGA | 4 weeks follow-up after treatment | No | |
Secondary | each index of SCORAD INDEX | TBSA, erythema, edema/papulation, oozing, excoriations, dryness, lichenification, pruritus, insomnia. | 4 weeks follow-up after treatment | Yes |
Secondary | serum Total IgE | 4 weeks follow-up after treatment | No | |
Secondary | Valuation of EASI | 4 weeks follow-up after treatment | No |
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