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Human Phototoxicity Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02750475
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : December 13, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Sunscreening Agents Drug: Sunscreen Sport Lotion (BAY987516) Other: Untreated Skin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Human Phototoxicity Test
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : May 6, 2016
Actual Study Completion Date : May 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arm Intervention/treatment
Experimental: Arm 1
All subjects are patched.
Drug: Sunscreen Sport Lotion (BAY987516)
50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)

Other: Untreated Skin
This site is patched without treatment as irradiated control

Primary Outcome Measures :
  1. Intensity of skin reactions will be evaluated using the 5 point grading scale [ Time Frame: Up to 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02750475

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United States, New Jersey
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer Identifier: NCT02750475    
Other Study ID Numbers: 18851
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Phototoxic
Dermatitis, Irritant
Dermatitis, Contact
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents