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CompletedNCT02750449Updated Dec 13, 2018

Human Photoallergy Test

An interventional study of Sun screening Sport Lotion, (BAY987516) 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
54
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sunscreening Agents
03

In context

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 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

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;
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Arm 1

    All subjects are patched.

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

Interventions

  • DrugSun screening Sport Lotion, (BAY987516)

    50 μl/ cm\*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm\*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110)

  • OtherUntreated skin

    This site is patched without treatment as control

06

What researchers measure

Primary outcomes

  1. Intensity of skin reactions is evaluated by 5 point grading scale

    Time frame: Up to 72 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
NCT02750449
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Apr 25, 2016
Start date
May 9, 2016
Primary completion
Jul 1, 2016
Completion
Jul 1, 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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Dermatitis, Photoallergic

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