None listed
Conditions
Interventions
Drug : alitretinoin 10 mg, 30mg QD, 24weeks
Sponsors
Soon Chun Hyang University Hospital Bucheon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female aged 19 years or older and under 75 years old 2) A patient with hand eczema who meets the severe criteria of the PGA, and the symptoms of hand eczema persisted for at least 12 weeks prior to screening or recurred twice or more within 48 weeks 3) Those who do not respond to strong topical corticosteroid therapy for at least 4 weeks for the treatment of hand eczema 4) Women and men of childbearing potential who fully understand the risks of pregnancy and contraceptive warnings and are willing to maintain contraceptive compliance 5) A person who voluntarily decides to participate in the clinical trial after hearing sufficient explanation and consents in writing
Exclusion criteria
Exclusion criteria: 1) Those who have bacterial, fungal or viral infection on their hands, or allergic contact dermatitis 2) Those who need drug treatment for psoriasis or atopic dermatitis 3) Those with serious skin diseases other than eczema that the investigator judges may affect the efficacy and safety evaluation of this clinical trial 4) Those with the following diseases at the time of screening or baseline ? Hepatic dysfunction: aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 x upper normal limit (UNL) ? Severe renal impairment: estimated glomerular filtration rate (eGFR)* 2.0 x UNL ? Hypercholesterolemia: total cholesterol or low-density lipoprotein cholesterol (LDL-C) >2.0 x UNL ? Hemoglobin abnormality: hemoglobin <UNL ? Hypothyroidism ? Vitamin A overdose ? Pancreatitis or symptoms suspected of pancreatitis according to the examiner's judgment 5) Those with a history of mental illness (eg depression, etc.) 6) Those who have the following medical history or drug administration history ? Ultraviolet B (UVB) phototherapy, psoralen and ultraviolet A radiation (PUVA) treatment, systemic glucocorticoid, retinoid, and immunosuppressant administration within 4 weeks before baseline ? Within 2 weeks before the baseline, systemic azoles, systemic erythromycin, systemic clarithromycin, systemic tetracycline, St. John's wort administration 7) Those who need treatment with combination contraindications (7.3.2 contraindications) as defined in this clinical trial during the clinical trial period 8) Pregnant or lactating women 9) Persons with hypersensitivity to and/or history of clinical investigational drugs, components, and retinoids 10) Those who are hypersensitive to soybean oil or have a history of allergy 11) Those with hypersensitivity to soybeans or peanuts 12) A person who has been administered or applied within 4 weeks prior to screening for other clinical investigational drugs or medical devices for clinical investigation 13) Those who are judged inappropriate to participate in this clinical trial by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PGA | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Lip Park
Soon Chun Hyang University Hospital Bucheon
Outcome results
None listed