Epidermolysis Bullosa
Conditions
Brief summary
Efficacy of TCP-25 gel as compared with the vehicle in terms of open index wound area until Day 56 relative to the baseline.
Detailed description
Key secondary point: Efficacy of TCP-25 gel as compared with the vehicle in terms of proportions of index wounds achieving complete closure of index wound (defined as 100% re-epithelialization without drainage), within Day 56., Change in procedural pain using the Wong Baker FACES® Pain Rating Scale Change from baseline in clinical impression of the index wound using the CGI-S scale and the CGI-C score, TCP-25 plasma concentrations Frequency, intensity, and seriousness of Adverse Events in all treated patients Local tolerability assessment at the area of IMP application Clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure and pulse rate) and physical examination
Interventions
DRUGTCP-25
DRUGSterile agent for cutaneous application
DRUGidentical to the composition of the TCP-25 gel
DRUGexcept it will not contain the active pharmaceutical ingredient
Sponsors
Xinnate AB
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of TCP-25 gel as compared with the vehicle in terms of open index wound area until Day 56 relative to the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary point: Efficacy of TCP-25 gel as compared with the vehicle in terms of proportions of index wounds achieving complete closure of index wound (defined as 100% re-epithelialization without drainage), within Day 56., Change in procedural pain using the Wong Baker FACES® Pain Rating Scale Change from baseline in clinical impression of the index wound using the CGI-S scale and the CGI-C score, TCP-25 plasma concentrations Frequency, intensity, and seriousness of Adverse Events in all treated patients Local tolerability assessment at the area of IMP application Clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure and pulse rate) and physical examination | — |
Countries
France, Greece, Italy, Spain, Sweden
Outcome results
None listed