NCT06119750

4-Day Primary Irritation Patch Test of MIS Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Next Science TM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Irritation/Irritant
• Reactions Adverse

Interventions

Type	Name	Description
DEVICE	NS Solution	This will be administered via skin patch.
OTHER	Normal Saline	This will be administered via skin patch.
OTHER	SLS	This will be administered via skin patch.

Timeline

• Start date: 2020-07-06
• Primary completion: 2020-07-16
• Completion: 2020-08-04
• First posted: 2023-11-07
• Last updated: 2023-11-07

Regulatory

• FDA-regulated device study