Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03036306
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
Sponsor:
ScarX Corp
Organization:
Study Overview
Official Title:
A Randomized, Placebo Controlled, Double-blind, Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
Status:
COMPLETED
Status Verified Date:
2017-10
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 purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the absorption and elimination of profiles of this topically applied product will be determined through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done but are considered exploratory.
Detailed Description:
None
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?: