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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: NCT02751489
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : June 17, 2016
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 Other: Bain De Soliel - Solid 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)
Official Title: Human Phototoxicity Test
Study Start Date : May 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Bain De Soliel - Solid
All subjects are patched with the same product
Other: Bain De Soliel - Solid
0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.

Primary Outcome Measures :
  1. Intensity of skin reactions is evaluated by 5 point 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 (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): NCT02751489

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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
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Responsible Party: Bayer Identifier: NCT02751489    
Other Study ID Numbers: 18600
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Dermatitis, Phototoxic
Dermatitis, Irritant
Dermatitis, Contact
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous