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4-Day Primary Irritation Patch Test of MIS Solution

NCT06119750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

  • Healthy
  • Irritation/Irritant
  • Reactions Adverse

Interventions

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.

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Next Science TM

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2020-07-16
Completion
2020-08-04
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119750 on ClinicalTrials.gov