Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay

Bayer11 enrolled

Overview

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sunscreen Agents

Interventions

BAY 987516DRUG

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

SPF 15 ControlDRUG

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female of an age of 18 to 70 years inclusive; * Fitzpatrick Skin Type I, II and/or III for SPF testing; * Good health as determined from the CRO Subject History Form (SHF); * Signed and dated Informed Consent Form; * Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; * An unambiguous minimal erythema dose (MED).

Locations (1)

Unnamed facility

Union, New Jersey, United States

Outcomes

Primary Outcomes

Evaluation of water resistant SPF

For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method.

Time frame: 16-24 hours post exposure

Data from ClinicalTrials.gov

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