Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01346969
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2011-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B5301004 | OTHER | Alias Study Number | View |