NCT02750475

Human Phototoxicity Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To determine the phototoxic potential of a topically applied article in human subjects

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
DRUG	Sunscreen Sport Lotion (BAY987516)	50 μl/cm\*2 or 0.05 gm/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm\*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)
OTHER	Untreated Skin	This site is patched without treatment as irradiated control

Timeline

• Start date: 2016-05-02
• Primary completion: 2016-05-06
• Completion: 2016-05-06
• First posted: 2016-04-25
• Last updated: 2018-12-13

Locations

1 site across 1 country: United States