NCT04531813

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

HT201307-Cumulative Irritation Patch Test (21 Day)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Butenafine HCl 1% (BAY1896425)	Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g.
DRUG	Positive Control-Sodium lauryl sulfate (SLS)	Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site.
OTHER	Negative Control	A blank patch was applied to the Negative Control test site.

Timeline

• Start date: 2013-06-10
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2020-08-31
• Last updated: 2020-09-25
• Results posted: 2020-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study