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

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

Completed

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Key information

Conditions

Sunscreen Agents

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union, New Jersey, 07083, United States

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

BAY 987516

Drug

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 Control

Drug

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.

Primary outcomes

Evaluation of water resistant SPF

Time frame: 16-24 hours post exposure

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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Aug 19, 2016
Registry last updated: Dec 12, 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