Cancerous Skin Ulcer
Conditions
Interventions
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 ar
Sponsors
Kyosuke Ishii
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactIshii Kyosuke
Otsuka Pharmaceutical Factory, Inc.
Outcome results
None listed