IL-12 Compassionate Use Study of the Treatment of Localized Radiation Skin Injury

JRCT ID: jRCTs031230407

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Radiation skin injury
• Date of first enrollment: 17/10/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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 administration.

NM-IL-12 non-treatment group:No placebo drug will be administered.

Outcome(s)

• Primary Outcome: The period from exposure to large doses of radiation to the occurrence or deterioration of skin damage.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hasegawa Arifumi
• Source(s) of Monetary Support: Libo Pharma Corp.