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Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

Hypersensitivity Clinical Trial

Official title:
HT201307-Cumulative Irritation Patch Test (21 Day)

Clinical Trial Summary

In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04531813
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date June 10, 2013
Completion date July 1, 2013
View Details
See also
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