Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT03502434
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers
Sponsor:
Biosplice Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Single-Center, Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution
Status:
COMPLETED
Status Verified Date:
2018-04
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:
This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.
Detailed Description:
This Phase 1, Repeat Insult Patch Test (RIPT) study is a single-center study of topical SM04755 solution repetitively applied to skin of healthy volunteers. This study will assess the potential of the Test Materials to induce contact sensitization as measured by treatment emergent adverse events (TEAEs), Reaction Grade and Investigator assessment of irritation and sensitization.
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?: