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: NCT02872246
• Other study ID #: 18321
• Status: Completed
• Phase: N/A
• Start date: May 26, 2015
• Est. completion date: July 1, 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: 11
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 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 987516
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 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.	16-24 hours post exposure

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.