Human Photoallergy Test

• ClinicalTrials.gov Identifier: NCT02750449
• Recruitment Status: Completed
• First Posted: April 25, 2016
• Last Update Posted: December 13, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

To evaluate the potential of a test material to produce a photo allergic response.

Condition or disease	Intervention/treatment	Phase
Sunscreening Agents	Drug: Sun screening Sport Lotion, (BAY987516); Other: Untreated skin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Human Photoallergy Test
• Actual Study Start Date: May 9, 2016
• Actual Primary Completion Date: July 1, 2016
• Actual Study Completion Date: July 1, 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: Arm 1; All subjects are patched.

Drug: Sun screening Sport Lotion, (BAY987516); 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110); Other: Untreated skin; This site is patched without treatment as control

Outcome Measures

Primary Outcome Measures :

1. Intensity of skin reactions is evaluated by 5 point grading scale [ Time Frame: Up to 72 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 Health Insurance Portability and Accountability Act (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;
• have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products;
• subjects who are employees of the CRO and/or Bayer or is a household member of an employee;

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: NCT02750449
• Other Study ID Numbers: 18852
• First Posted: April 25, 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

Additional relevant MeSH terms:

Dermatitis, Photoallergic; Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatitis; Skin Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases