Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594393
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
A Phase 2 Study of TCP-25 Gel in Patients with Epidermolysis Bullosa STEP-study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Vehicle-controlled Phase 2 Study to Evaluate Efficacy Safety and Tolerability of Topically Applied TCP-25 in Patients with Epidermolysis Bullosa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP
Brief Summary:
This is a Phase 2 double-blind randomized vehicle-controlled study designed to evaluate efficacy safety and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB The study will implement intrasubject randomization ie pairs of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel
Detailed Description:
The study will include a Screening Period a Treatment Period Days 1 to 56 with study visits conducted every 2 weeks including the baseline Day 1 Day 14 Day 28 Day 42 and Day 56 visits and a Safety Follow-up conducted via a telephonevideo call at approximately 14 days after the last dose of the IMP Patients will undergo efficacy safety tolerability and PK assessments at scheduled visits For evaluation of the primary efficacy endpoint a trained clinician will take the images of the index wounds at all scheduled visits from baseline through Day 56 Visit 6 using 3D digital photography and software for wound measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None