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

Last updated: October 21, 2020
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Rash

Allergy

Treatment

N/A

Clinical Study ID

NCT04531527
18154
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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'smedical history;
  • Participants must have been willing to avoid tanning bed usage and additional sunexposure during the trial and follow-up period;
  • Participants must have been willing to refrain from using any new topical productsduring the trial;
  • Participants must have been able and willing to cooperate with the Investigator andresearch staff, to have test materials applied according to protocol, and to completethe full course of the trial;
  • Participants must have been willing to report any medications taken during the trialand refrain from taking any medications during the trial that might producephotoreactions;
  • If female, participants must produce a negative urine pregnancy test prior to theinitiation and also at the completion of the trial.

Exclusion

Exclusion Criteria:

  • Participants must not have had visible sunburn;
  • Participants must not have had a history of sun hypersensitivity/photosensitivity, orphotosensitive 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 couldhave caused a photoreaction or may have interfered with the trial;
  • Participants must not have had any known skin conditions that might interfere with theproper conduct of the trial;
  • Participants must not have had scars, moles, excessive hair, or other blemishes overthe mid or lower back which might have interfered with the test or the grading of thetest sites;
  • Participants must not have had significant history of internal disease that may haveinterfered with the evaluation of the test material as determined by the Investigator;
  • Participants must not have been pregnant, planning pregnancy, or nursing a childduring the trial period;
  • Participants must not have used a tanning bed or other artificial tanning lightswithin the past two months;
  • Participants must not have participated in a patch test involving the back within fourweeks prior to the start of the trial;
  • Participants must not have concurrently participated in any other clinical or consumertest;
  • Participants must not have had other conditions considered by the Investigator assound reasons for disqualification from enrollment into the trial.

Study Design

Total Participants: 32
Study Start date:
June 24, 2013
Estimated Completion Date:
June 28, 2013

Connect with a study center

  • Fairfield, New Jersey 07004
    United States

    Site Not Available

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