Clinical trial of OPF-501C in patients with cancerous skin ulcers

JRCT ID: jRCT2051230016

Registered date:13/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cancerous Skin Ulcer
• Date of first enrollment: 01/04/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Apply OPF-501C at an appropriate thickness so that the affected area (cancerous skin ulcer site to be treated) is not seen through. The investigational drug is removed after acting on the affected area according to its condition.

Outcome(s)

Primary Outcome

Presence/absence of oozing bleeding immediately after the 1st use of the investigational drug
Presence/absence of oozing bleeding 1 day after the 1st use of the investigational drug
Presence/absence of oozing bleeding 7 days after the 1st use of the investigational drug
Presence/absence of oozing bleeding immediately after the 2nd use of the investigational drug
Presence/absence of oozing bleeding 1 day after the 2nd use of the investigational drug
Presence/absence of oozing bleeding 7 days after the 2nd use of the investigational drug
bleeding and exudate volume 1 day after the 1st use of the investigational drug
bleeding and exudate volume 7 days after the 1st use of the investigational drug
bleeding and exudate volume 1 day after the 2nd use of the investigational drug
bleeding and exudate volume 7 days after the 2nd use of the investigational drug

Secondary Outcome

Score of bleeding conditions at the site of cancerous skin ulcer immediately after the 1st use of the investigational drug
Score of bleeding conditions at the site of cancerous skin ulcer 1 day after the 1st use of the investigational drug
Score of bleeding conditions at the site of cancerous skin ulcer 7 days after the 1st use of the investigational drug
Score of bleeding conditions at the site of cancerous skin ulcer immediately after the 2nd use of the investigational drug
Score of bleeding conditions at the site of cancerous skin ulcer 1 day after the 2nd use of the investigational drug
Score of bleeding conditions at the site of cancerous skin ulcer 7 days after the 2nd use of the investigational drug
Score of blood adherence to gauze immediately after the 1st use of the investigational drug
Score of blood adherence to gauze 1 day after the 1st use of the investigational drug
Score of blood adherence to gauze 7 days after the 1st use of the investigational drug
Score of blood adherence to gauze immediately after the 2nd use of the investigational drug
Score of blood adherence to gauze 1 day after the 2nd use of the investigational drug
Score of blood adherence to gauze 7 days after the 2nd use of the investigational drug
Duration of bleeding and exudate control during the 1st use of the investigational drug
Duration of bleeding and exudate control during the 2nd use of the investigational drug
Score of odor immediately after 1st use of investigational drug
Score of odor 1 day after the 1st use of the investigational drug
Score of odor 7 days after the 1st use of the investigational drug
Score of odor immediately after the 2nd use of the investigational drug
Score of odor 1 day after the 2nd use of the investigational drug
Score of odor 7 days after the 2nd use of the investigational drug
Size of cancerous skin ulcer 7 days after 1st use of investigational drug
Size of cancerous skin ulcer 7 days after 2nd use of investigational drug
Score of DLQI 7 days after 1st use of investigational drug
Score of DLQI 7 days after 2nd use of investigational drug

Key inclusion & exclusion criteria

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

Include criteria

1. Patients with a short diameter of 5 cm or more than or equal to at the site of the cancerous skin ulcer to be treated
2. Patients with bleeding or evidence of bleeding at the site of the cancerous skin ulcer to be treated
3. Patients with exudate at the site of the cancerous skin ulcer to be treated
4. Patients who are aged 18 years or older at the time of consent
5. Patients who are able to consent and sign a written consent by oneself

Exclude criteria

1. Patients whose cancerous skin ulcer site is to be treated corresponds to any of the following:
1) With eruptive or pulsatile bleeding
2) Anatomically evident presence of large blood vessels, nerves, or organs in the vicinity, and the action of the investigational drug is expected to affect them
3) Present in the vicinity of a tracheostomy
4) Present in the vicinity of mucous membranes (eye, mouth, pubic region, etc.)."
2. Patients with a history of hypersensitivity to any of the ingredients of the investigational drug
3. Patients whose bleeding is limited to the boundary between the site of the cancerous skin ulcer being treated and normal skin
4. Patients who are pregnant or may be pregnant
5. Patients who have used or received an investigational or unapproved drug or other drugs within 4 weeks prior to the enrollment
6. Patients who have previously used the Mohs Paste
7. Other patients deemed inappropriate for this study by the principal investigator

Related Information

• Primary Sponsor: Kyosuke Ishii