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
Condition: Dermatitis, Phototoxic
MeSH terms: Dermatitis; Dermatitis, Phototoxic
Intervention: Butenafine HCl 1% (BAY1896425)
Intervention description: 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%.
Intervention MeSH terms: Butenafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have been between the ages of 18 and 60 years;

          -  Participants must have been lightly pigmented (Fitzpatrick skin phototypes I, II,
             III);

          -  Participants must have been in good general health as determined by the subject's
             medical history;

          -  Participants must have been willing to avoid tanning bed usage and additional sun
             exposure during the trial and follow-up period;

          -  Participants must have been willing to refrain from using any new topical products
             during the trial;

          -  Participants must have been able and willing to cooperate with the Investigator and
             research staff, to have test materials applied according to protocol, and to complete
             the full course of the trial;

          -  Participants must have been willing to report any medications taken during the trial
             and refrain from taking any medications during the trial that might produce
             photoreactions;

          -  If female, participants must produce a negative urine pregnancy test prior to the
             initiation and also at the completion of the trial.

        Exclusion Criteria:

          -  Participants must not have had visible sunburn;

          -  Participants must not have had a history of sun hypersensitivity/photosensitivity, or
             photosensitive dermatoses;

          -  Participants must not have had a history of allergies or sensitivities to cosmetics,
             toiletries, or any dermatological products;

          -  Participants must not have recently used any systemic or topical drugs which could
             have caused a photoreaction or may have interfered with the trial;

          -  Participants must not have had any known skin conditions that might interfere with the
             proper conduct of the trial;

          -  Participants must not have had scars, moles, excessive hair, or other blemishes over
             the mid or lower back which might have interfered with the test or the grading of the
             test sites;

          -  Participants must not have had significant history of internal disease that may have
             interfered with the evaluation of the test material as determined by the Investigator;

          -  Participants must not have been pregnant, planning pregnancy, or nursing a child
             during the trial period;

          -  Participants must not have used a tanning bed or other artificial tanning lights
             within the past two months;

          -  Participants must not have participated in a patch test involving the back within four
             weeks prior to the start of the trial;

          -  Participants must not have concurrently participated in any other clinical or consumer
             test;

          -  Participants must not have had other conditions considered by the Investigator as
             sound reasons for disqualification from enrollment into the trial.