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CompletedNCT02857738Updated Dec 12, 2018

Sun Protection Factor (SPF) - Static and Water Resistant Assay

An interventional study of BAY 987519 and SPF 15 Control in Sunscreen Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Bayer · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2015, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sunscreen Agents
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    SPF evaluation

    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.

    Drug: BAY 987519 · Drug: SPF 15 Control

Interventions

  • DrugBAY 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.

  • DrugSPF 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.

06

What researchers measure

Primary outcomes

  1. Evaluation of water resistant SPF in accordance to ISO 24444

    Time frame: 16-24 hrs post exposure

07

Study locations

1 site
  • Union, New Jersey 07083, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02857738
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
May 26, 2015
Primary completion
Jun 10, 2015
Completion
Jun 10, 2015
Last update
Dec 12, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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