CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
Butenafine HCl 1% (BAY1896425)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04531527
NCT04531527Phase 3Completed
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HT201308- Human Phototoxicity Test

Bayer·interventional·Posted Aug 28, 2020·Updated Nov 13, 2020

In Brief

A Phase 3 clinical trial evaluating Butenafine HCl 1% (BAY1896425) for Dermatitis, Phototoxic. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Phototoxic
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 28, 2020
Enrollment StartJun 24, 2013
Primary CompletionJun 28, 2013
TodayJul 2, 2026
Enrollment to primary: 4 daysPosted 5.8 years ago

Interventions

Butenafine HCl 1% (BAY1896425)drug

Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.