Trial Condition(s):
Sunscreening Agents
Human Phototoxicity Test
Bayer Identifier:
18600
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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 Health Insurance Portability and Accountability (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; -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
Trial Summary
Enrollment Goal
35
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Piscataway, United States, 08854 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Human Phototoxicity Test
Trial Type:
Interventional
Intervention Type:
Other
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Intensity of skin reactions is evaluated by 5 point scaleTimeframe: Up to 48 hours
Additional Information
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