Radiation skin injury
Conditions
Interventions
NM-IL-12 group:A single subcutaneous dose of NM-IL-12,12 microg is administered within 24 hours (48 hours is acceptable if difficult) after exposure.There will be no restriction on the site of adminis
Sponsors
Hasegawa Arifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are 18 years of age or older at the time of obtaining consent 2) Subjects who are considered to have received an estimated exposure dose of 1 Gy or more 3) Subjects who are assumed to require symptomatic treatment due to skin damage caused by radiation exposure 4) Subjects who have given written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects who are expected to undergo bone marrow transplantation due to radiation exposure 2) Subjects using drugs that affect the effects of NM-IL-12 3) Subjects who are pregnant or breastfeeding 4) Unable to use contraception for 90 days after NM-IL-12 administration (not applicable in the NM-IL-12 non-treatment group) 5) Other Subjects who are judged to be ineligible as subjects by the principal investigator, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The period from exposure to large doses of radiation to the occurrence or deterioration of skin damage. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Items related to effectiveness 1. Reduction rate of ulcer 2. Incidence of skin infections 3. Evaluation of skin biopsy samples: Histopathological examination 4. Evaluation of skin biopsy samples: amount of collagen 2) Items related to safety 1. Disease or the like 2. Subjective symptoms/objective findings 3. Vital signs 4. Clinical examination | — |
Contacts
Public ContactArifumi Hasegawa
Fukushima Medical University Hospital
Outcome results
None listed