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NCT04531813 · ClinicalTrials.gov registry record · Phase 3
Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT04531813 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 32 participants.
The verdict
NCT04531813, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG Butenafine HCl 1% (BAY1896425)
- OTHER Negative Control
- DRUG Positive Control-Sodium lauryl sulfate (SLS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-06-10 |
| Est. Completion | 2013-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04531813
The ClinicalTrials.gov registry entry for NCT04531813 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Butenafine HCl 1% (BAY1896425) is the first listed.
NCT04531813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04531813 about?
NCT04531813 is a clinical study titled "Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)". 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 ...
What is the current status of trial NCT04531813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2013-06-10. Estimated completion is 2013-07-01.
What interventions are being tested in trial NCT04531813?
The interventions under investigation include: Butenafine HCl 1% (BAY1896425) (DRUG), Negative Control (OTHER), Positive Control-Sodium lauryl sulfate (SLS) (DRUG).
Who is sponsoring clinical trial NCT04531813?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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