Human Photoallergy Test

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Other: Untreated skin; Other: Bain De Soliel - Solid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02751515

18601

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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
• 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 Contract Research Organization (CRO) and/or Bayer or is a household member of an employee

Trial design

54 participants in 1 patient group

Bain De Soliel - Solid

Experimental group

Description:

All subjects are patched with the same product

Treatment:

Other: Bain De Soliel - Solid

Other: Untreated skin