CompletedInterventionalNot ApplicableUpdated Dec 13, 2018
Human Phototoxicity Test | NCT02754102 | Trialant
CompletedInterventionalNot ApplicableUpdated May 1, 2017
Human Phototoxicity Test
Human Phototoxicity Test
ClinicalTrials.gov ID
NCT02754102
Lead Sponsor
BayerINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
35Actual
Last Update Posted
May 1, 2017Actual
Start Date
May 3, 2016Actual
Primary Completion Date
May 6, 2016Actual
Completion Date
May 6, 2016Actual
Official Title
Human Phototoxicity Test
Brief Summary
To determine the phototoxic potential of a topically applied article in human subjects.
Sunscreening Agents
Sunscreen Spray- Liquid (BAY987516)
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 HIPAA (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) 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 dermatosis;
must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.