18349-Human Photoallergy Test | Clinical Trial

Key information

Conditions

Sunscreening Agents

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piscataway, New Jersey, 08854, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
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

Treatment and study plan

Sunscreen Lotion , BAY 987521

Other

50 μl/ cm2 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 3μl/cm2 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 A: Y49-103, Formulation B: Y71-150.

Untreated Skin

Other

One site is patched without treatment as control

Primary outcomes

Intensity of skin reactions is evaluated by 5 point scale

Time frame: Up to 72 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Human Photoallergy Test

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 6, 2016
Registry last updated: Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed