Human Photoallergy Test

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Bayer

Status

Completed

Conditions

Sunscreening Agents

Treatments

Other: Untreated skin
Drug: Sun screening Sport Lotion, (BAY987516)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02750449
18852

Details and patient eligibility

About

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

54 participants in 1 patient group

Arm 1
Experimental group
Description:
All subjects are patched.
Treatment:
Drug: Sun screening Sport Lotion, (BAY987516)
Other: Untreated skin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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