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NCT04531540 · ClinicalTrials.gov registry record · Phase 3
Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT04531540 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 225 participants.
The verdict
NCT04531540, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study 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.
Interventions
- DRUG Butenafine HCl 1% (BAY1896425)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2013-09-09 |
| Est. Completion | 2013-10-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04531540
The ClinicalTrials.gov registry entry for NCT04531540 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 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 1 intervention - of which Butenafine HCl 1% (BAY1896425) is the first listed.
NCT04531540 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04531540 about?
NCT04531540 is a clinical study titled "Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)". 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 t...
What is the current status of trial NCT04531540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2013-09-09. Estimated completion is 2013-10-18.
What interventions are being tested in trial NCT04531540?
The interventions under investigation include: Butenafine HCl 1% (BAY1896425) (DRUG).
Who is sponsoring clinical trial NCT04531540?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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