CClinicalTrials.gg
Sign In
CompletedNCT02930746Updated Dec 13, 2018

Sun Protection Factor Assay (SPF Assay 199/2016)

An interventional study of BAY987516 in Sunscreening 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 2018-12-13.

Sponsored by Bayer · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the Sun Protection Factor efficacy on human skin.

02

Conditions studied

  • Sunscreening 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

Inclusion criteria

  • Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
  • Male and female.
  • Aged between 18-70 years old.
  • Good health as determined from the HRL SHF (Subject History Form).
  • Signed and dated Informed Consent Form.
  • Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
  • An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion criteria

Exclusion Criteria:

  • Subjects on test at any other research laboratory or clinic.
  • Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
  • Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
  • Pre-existing other medical conditions (e.g. adult asthma, diabetes).
  • Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
  • Treatment with antibiotics within two weeks prior to initiation of the test.
  • Chronic medication which could affect the results of the study.
  • Known pregnant or nursing women.
05

Study design

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

Study arms

  • Experimental
    BAY987516

    Each test site area is divided into test sub site areas that are approximately at least 0.5 cm\*2. The application of test material is 2 mg/cm\*2. Thus, each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application.

    Drug: BAY987516

Interventions

  • DrugBAY987516

    Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application. (Formulation Code: Z46-092)

06

What researchers measure

Primary outcomes

  1. Minimal Erythema Dose (MED)

    Time frame: Up to 15 minutes

  2. Minimal Persistent Pigment Darkening Dose (MPPD)

    Time frame: Up to 15 minutes

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 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02930746
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Oct 12, 2016
Start date
Oct 12, 2016
Primary completion
Oct 13, 2016
Completion
Oct 13, 2016
Last update
Dec 13, 2018

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Bayer

Start the discussion