Study Completed

Sunscreen agents

Bayer Identifier:

18321

ClinicalTrials.gov Identifier:

NCT02872246

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 70 Years

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).
Exclusion Criteria

Trial summary

Enrollment Goal

Trial Dates

May 2015 - July 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987516

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Union, 07083, United States

Primary Outcome

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.
Time Frame:
16-24 hours post exposure
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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.