Human Phototoxicity Test

N/ACompletedNCT02751541

Bayer35 enrolled

Overview

To determine the phototoxic potential of a topically applied article in human subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sunscreening Agents

Interventions

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 SkinOTHER

This site is patched without treatment as irradiated control.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Piscataway, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 48 hours

Data from ClinicalTrials.gov

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