Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-04 @ 12:11 PM
Study NCT ID:
NCT01689857
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.
Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number
Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number
Detailed Description:
For evaluating the efficacy
* The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
* The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.
* The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
* The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 06-2010-049 | OTHER_GRANT | ILDONG Pharmaceutical CO. LTD. | View |