NCT04531540

Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

HT201321- Repeated Insult Patch Test With Modified Challenge

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Butenafine HCl 1% (BAY1896425)	Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.

Timeline

• Start date: 2013-09-09
• Primary completion: 2013-10-18
• Completion: 2013-10-18
• First posted: 2020-08-28
• Last updated: 2020-11-17
• Results posted: 2020-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study