Sun Protection Factor (SPF) Assay

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY 987517; Drug: SPF 15 Control

• Registration Number: NCT02857725
• 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: 2015-05-18
• Primary Completion: 2015-06-09
• Study Completion: 2015-06-09
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF evaluation	BAY 987517	Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were considered 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 considered for SPF testing.

Primary Outcome Measures

Name	Time	Method
Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327	16-24 h post exposure