18794 - Human Photo Toxicity Test

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Bayer

Status

Completed

Conditions

Sunscreening Agents

Treatments

Drug: BAY 987517
Other: Untreated Skin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02751372
18794

Details and patient eligibility

About

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

Enrollment

35 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 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

BAY 987517
Experimental group
Description:
All subjects are patched .
Treatment:
Other: Untreated Skin
Drug: BAY 987517

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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