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

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY 987516; Drug: SPF 15 Control

• Registration Number: NCT02872246
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-26
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-19
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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).

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF evaluation	BAY 987516	Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.
SPF evaluation	SPF 15 Control	Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.

Primary Outcome Measures

Name	Time	Method
Evaluation of water resistant SPF	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.