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NCT04531527 · ClinicalTrials.gov registry record · Phase 3
Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects
A Phase 3 study of Dermatitis, Phototoxic, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04531527: Completed Phase 3 study of Dermatitis, Phototoxic, sponsored by Bayer.
NCT04531527 is a Phase 3 study of Dermatitis, Phototoxic that has completed, run by Bayer. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04531527, a Phase 3 study of Dermatitis, Phototoxic, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be applied to the skin of healthy human subjects. By using a solar simulator to generate a UV spectrum similar to that of sunlight the potential of the study drug to produce a superficial reddening of the skin will be measured.
Primary Outcome
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scor
Conditions Studied
Interventions
- DRUG Butenafine HCl 1% (BAY1896425)
Study Locations (1)
New Jersey
- - Fairfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-06-24 |
| Est. Completion | 2013-06-28 |
| Phase | Phase 3 |
What the finished NCT04531527 record still lists
NCT04531527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Dermatitis, Phototoxic appearing as the primary indexed condition, and to 1 intervention - of which Butenafine HCl 1% (BAY1896425) is the first listed.
NCT04531527 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04531527 about?
NCT04531527 is a clinical study titled "Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects". In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be ap...
What is the current status of trial NCT04531527?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2013-06-24. Estimated completion is 2013-06-28.
What conditions does trial NCT04531527 study?
This clinical trial studies the following conditions: Dermatitis, Phototoxic.
What interventions are being tested in trial NCT04531527?
The interventions under investigation include: Butenafine HCl 1% (BAY1896425) (DRUG).
Who is sponsoring clinical trial NCT04531527?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04531527 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04531527's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 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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