Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07473661
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
Study:
NCT07473661
Study Brief:
Protocol Section:
NCT07473661