JPRN-UMIN000028366
Completed
Phase 1
A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients. - A clinical study to evaluate efficacy, safety and tolerability of ISN001 in dystrophic epidermolysis bullosa patients.
Conditionsdystrophic epidermolysis bullosa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- dystrophic epidermolysis bullosa
- Sponsor
- Ishin Pharmaceutical Co. Ltd.
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1\)Patients with the following medical histories. 1\)Patients who are being suffered from squamous cell carcinoma except more than one year has passed without relapses following surgical operations. 2\)Patients with severe allergic reactions such as shock and/or anaphylaxis clinical symptoms 3\)Patients with skin hypersensitivities against topically applied medicines. 4\)Patients with allergies against xenogeneic proteins 5\)Patients with allergies against penicillin, streptomycin and/or amphotericin B. 2\) Patients with the following complications. 1\) Severe functional failures in the liver, heart and/or lung. (3\)Patients who underwent the following conditions within one year of the day of initiation of this study. 1\) Drug abuses 2\) Alcohol dependencies (4\)Patients who participated in other clinical trials and/or intervention studies within 4 months (120 days) of the day of initiation of this study. (5\)Patients who are considered not suitable for the study by principal investigator.
Outcomes
Primary Outcomes
Not specified
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