Last updated: October 21, 2020
Sponsor: Bayer
Overall Status: Completed
Phase
3
Condition
Rash
Allergy
Treatment
N/AClinical Study ID
NCT04531527
18154
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
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 StatesSite Not Available

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