18794 - Human Photo Toxicity Test

• ClinicalTrials.gov Identifier: NCT02751372
• Recruitment Status: Completed
• First Posted: April 26, 2016
• Last Update Posted: December 13, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sunscreening Agents	Drug: BAY 987517; Other: Untreated Skin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Human Phototoxicity Test
• Actual Study Start Date: May 2, 2016
• Actual Primary Completion Date: May 6, 2016
• Actual Study Completion Date: May 6, 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: BAY 987517; All subjects are patched .

Drug: BAY 987517; 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.; Other: Untreated Skin; This site is patched without treatment as irradiated control

Outcome Measures

Primary Outcome Measures :

1. Intensity of skin reactions will be evaluated using 5 point grading scale [ Time Frame: Up to 48 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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.

Contacts and Locations

Locations

United States, New Jersey

Piscataway, New Jersey, United States, 08854

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02751372
• Other Study ID Numbers: 18794
• First Posted: April 26, 2016
• Last Update Posted: December 13, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No