Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:53 AM
Study NCT ID:
NCT07473661
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix
Sponsor:
SerenaGroup, Inc.
Organization:
Study Overview
Official Title:
Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product Under Controlled and Maximized Conditions
Status:
RECRUITING
Status Verified Date:
2026-03
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:
HRIPT
Brief Summary:
The goal of this clinical trial is to evaluate the skin irritation and sensitization potential of SILURCLOUD™ Fibrous Collagen Matrix in healthy adult volunteers with Fitzpatrick Skin Types I and VI. The study will also generate additional safety data to address FDA 510(k) feedback regarding representation of these skin types.
The main questions it aims to answer are:
Does SILURCLOUD™ Fibrous Collagen Matrix cause primary or cumulative skin irritation under maximized patch test conditions?
Does SILURCLOUD™ Fibrous Collagen Matrix demonstrate allergic contact sensitization potential in human subjects?
Participants will:
Have patches containing the test product applied to the skin under occlusive conditions
Return for repeated patch applications during the induction phase
Undergo skin evaluations using standardized scoring methods
Complete a challenge phase following a rest period
Participate in re-challenge testing if clinically indicated
The main questions it aims to answer are:
Does SILURCLOUD™ Fibrous Collagen Matrix cause primary or cumulative skin irritation under maximized patch test conditions?
Does SILURCLOUD™ Fibrous Collagen Matrix demonstrate allergic contact sensitization potential in human subjects?
Participants will:
Have patches containing the test product applied to the skin under occlusive conditions
Return for repeated patch applications during the induction phase
Undergo skin evaluations using standardized scoring methods
Complete a challenge phase following a rest period
Participate in re-challenge testing if clinically indicated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: