4-Day Primary Irritation Patch Test of MIS Solution

Status Completed

Clinical Trial Summary

This is a 7 day primary irritation patch test. This study investigates the irritation potential of Next Science MIS Wound Irrigation Solution under standardized conditions compared with an inert control (normal saline) and a known irritant, 20% sodium dodecyl sulfate (also known as sodium lauryl sulfate [SLS]) solution in deionized water [DI] water) on intact skin of healthy human subjects.

Clinical Trial Description

In accordance with ISO 10993-10:2010(E), study products will be delivered via dermal patch at 15 and 30 minutes (min) and up to 1-hour (h), 2-h, 3-h, 4-h and then, pending results, 24-h (evaluated up to at least 48-h) continuous exposure. Response rate will be evaluated immediately after application then 1 h, 2 h, 24 h, 48 h, and then 72 h post-exposure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06119750
Study type	Interventional
Source	Next Science TM
Contact
Status	Completed
Phase	N/A
Start date	July 6, 2020
Completion date	August 4, 2020

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