CompletedInterventionalNot ApplicableUpdated Dec 13, 2018
Human Photoallergy Test
Human Photoallergy Test
ClinicalTrials.gov ID
NCT02750449
Lead Sponsor
BayerINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
54Actual
Last Update Posted
Dec 13, 2018Actual
Start Date
May 9, 2016Actual
Primary Completion Date
Jul 1, 2016Actual
Completion Date
Jul 1, 2016Actual
Official Title
Human Photoallergy Test
Brief Summary
To evaluate the potential of a test material to produce a photo allergic response.
Sunscreening Agents
Sun screening Sport Lotion, (BAY987516)
Untreated skin
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
be male or female between the ages of 18 and 60 inclusive;
be lightly pigmented (Fitzpatrick Skin Type I, II, III);
have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
be in general good health as determined by the subject's medical history and in the discretion of the investigator;
Exclusion Criteria:
have a visible sunburn;
have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products;
subjects who are employees of the CRO and/or Bayer or is a household member of an employee;