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CompletedNCT02962856Updated Dec 13, 2018

Human Phototoxicity Test (823/2016)

An interventional study of BAY987517 and Untreated Skin in Sunscreening Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by Bayer · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sunscreening Agents

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03

In context

Dermatitis, Phototoxic

22 studies on the registry are indexed under Dermatitis, Phototoxic; 1 is open to participants now.

This study's enrollment of 38 is close to the median of 35 across 19 interventional studies indexed under Dermatitis, Phototoxic.

Browse Dermatitis, Phototoxic studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • have a visible sunburn;
  • have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    BAY987517

    All subjects are patched with the same product.

    Drug: BAY987517 · Other: Untreated Skin

Interventions

  • DrugBAY987517

    50 μl/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078)

  • OtherUntreated Skin

    This site is patched without treatment as irradiated control

06

What researchers measure

Primary outcomes

  1. Intensity of skin reactions will be evaluated using the 5 point grading scale

    Time frame: Up to 48 hours

07

Study locations

1 site
  • Piscataway, New Jersey 08854, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02962856
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Nov 11, 2016
Start date
Nov 2, 2016
Primary completion
Nov 5, 2016
Completion
Nov 5, 2016
Last update
Dec 13, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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