JPRN-jRCT2033210128
Recruiting
Phase 3
A confirmatory clinical study to evaluate efficacy and safety of ISN001 in patients with epidermolysis bullosa
Ishiko Akira0 sites8 target enrollmentMay 31, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ishiko Akira
- Enrollment
- 8
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is eligible for the trial if it meets all of the following inclusion criteria:
- •(1\) Dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB), or Dowling\-Meara type of epidermolysis bullosa simplex (EBS) patient, diagnosed according to the intractable disease diagnostic criteria designated by the Ministry of Health, Labor and Welfare
- •(2\) Subject with skin ulcer lesions of epidermolysis bullosa meet the following criteria, on Visit 1 (Day starting the observation) in screening phase and Visit 3 (Day starting treatment):
- •1\) Subject has the skin ulcers lesion continuously lasting during the observation period in screening phase
- •2\) Subject with the skin ulcer lesion with total size of 10 \- 250 cm2
- •(3\) Subject with the size of skin ulcer lesion with (\+/\-) 20% change at both Visit 2 (Day of two weeks after Visit 1\) and Visit 3 (Day starting treatment) in comparison to Visit 1
- •(4\) Subject who has no clinical signs related to infection, or no visible necrosis in the ulcer lesion where ISN001 is applied
- •(5\) Subject aged 1 \- 70 years on the date of consent
- •(6\) Outpatient or hospitalized patient
- •(7\) Prior to recruitment, subject or his/her legal deputy (in the case of an infant subject, both the subject and the deputy) sign the form of informed consent after the nature of the trial and the profile of clinical product are explained
Exclusion Criteria
- •Subject with the following criteria / condition is excluded from the trial:
- •(1\) Subject with the following medical history
- •1\) Severe allergy (shock, anaphylaxis symptoms)
- •2\) Cutaneous hypersensitivity to topical medications
- •3\) Allergy to bovine or porcine protein or constituent of fibrin hydrogel sheet
- •4\) Allergy to penicillin, streptomycin or amphotericin B
- •(2\) Subject with malignant tumor or with a history of malignant tumor within 5 years before Visit 1 (Day stating observation)
- •(3\) Subject with advanced hepatic, cardiac or pulmonary disorders requiring hospitalization, providing that subject undergoing hemodialysis may be associated with renal amyloidosis, so the PI (principal investigator) or sub\-investigator in charge of the trial should carefully determine if the recruitment is appropriate or not
- •(4\) Subject with the following condition within 1 year prior to recruitment:
- •1\) Drug abuse
Outcomes
Primary Outcomes
Not specified
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