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

Sunscreen Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872233
• Other study ID #: 18319
• Status: Completed
• Phase: N/A
• Start date: May 26, 2015
• Est. completion date: June 10, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 10, 2015
• Est. primary completion date: June 10, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sunscreen Agents

Intervention

Drug:
• BAY 987519
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of 2 hours water resistant SPF	ISO/COLIPA Sun Protection FactorTest Method.	16-24 h post exposure

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