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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: Completed Phase 3 study, sponsored by Bayer.
NCT04531540 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
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 |
What the finished NCT04531540 record still lists
NCT04531540 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Butenafine HCl 1% (BAY1896425) is the first listed.
NCT04531540 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04531540's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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