Human Phototoxicity Test
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 5/28/2016 |
| Start Date: | May 2016 |
| End Date: | May 2016 |
| Contact: | Bayer Clinical Trials Contact |
| Email: | clinical-trials-contact@bayerhealthcare.com |
To determine the phototoxic potential of a topically applied article in human subjects.
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.
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