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NCT04532164 · ClinicalTrials.gov registry record · Phase 3
Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
A Phase 3 study of Dermatitis, Photoallergic, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
- 1
- Study location
NCT04532164: Completed Phase 3 study of Dermatitis, Photoallergic, sponsored by Bayer.
NCT04532164 is a Phase 3 study of Dermatitis, Photoallergic that has completed, run by Bayer. The registered enrollment target is 137 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04532164, a Phase 3 study of Dermatitis, Photoallergic, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
- 1
- Study location
Study Summary
Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms). Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.
Primary Outcome
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site
Conditions Studied
Interventions
- DRUG Butenafine HCl 1% (BAY1896425) - Induction Phase
- DRUG Butenafine HCl 1% (BAY1896425) - Challenge Phase
Study Locations (1)
New Jersey
- - Fairfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2013-06-10 |
| Est. Completion | 2013-11-11 |
| Phase | Phase 3 |
What the finished NCT04532164 record still lists
NCT04532164 is an interventional study that assigns participants to a tested intervention. The registered 137 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 (82% lower).
The record links to 1 condition, with Dermatitis, Photoallergic appearing as the primary indexed condition, and to 2 interventions - of which Butenafine HCl 1% (BAY1896425) - Induction Phase is the first listed.
NCT04532164 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04532164 about?
NCT04532164 is a clinical study titled "Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants". Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted ...
What is the current status of trial NCT04532164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2013-06-10. Estimated completion is 2013-11-11.
What conditions does trial NCT04532164 study?
This clinical trial studies the following conditions: Dermatitis, Photoallergic.
What interventions are being tested in trial NCT04532164?
The interventions under investigation include: Butenafine HCl 1% (BAY1896425) - Induction Phase (DRUG), Butenafine HCl 1% (BAY1896425) - Challenge Phase (DRUG).
Who is sponsoring clinical trial NCT04532164?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04532164 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 NCT04532164's enrollment target sits among peer trials
137 1580th of 2000 higher than 421 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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