Human Photoallergy Test

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Other: Bain De Soliel - Solid; Other: Untreated skin

• Registration Number: NCT02751515
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-05
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bain De Soliel - Solid	Bain De Soliel - Solid	All subjects are patched with the same product
Bain De Soliel - Solid	Untreated skin	All subjects are patched with the same product

Primary Outcome Measures

Name	Time	Method
Intensity of skin reactions is evaluated by 5 point scale	Up to 72 hours