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14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

NCT02309294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-10-12

Study results available
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Summary

The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.

Conditions

  • Cumulative Irritation

Interventions

DEVICE

Novel lubricant Miami w/ fragrance

0.2 ml aliquot on occlusive patch

DEVICE

Novel lubricant Miami no fragrance

0.2 ml aliquot on occlusive patch

DEVICE

KY Liquid lubricant

0.2 ml aliquot on occlusive patch

DEVICE

Astroglide Gel lubricant

0.2 ml aliquot on occlusive patch

DEVICE

Wet Platinum lubricant

0.2 ml aliquot on occlusive patch

Sponsors & Collaborators

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT02309294 on ClinicalTrials.gov