Human Phototoxicity 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 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.

Treatment and study plan

Sunscreen Sport Spray (BAY987519)

Drug

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#Y51-002)

Untreated Skin

Other

This site is patched without treatment as irradiated control.

Primary outcomes

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

Time frame: Up to 48 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Apr 26, 2016
Registry last updated: Dec 13, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed