check_circleStudy 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
  • - 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).

Trial summary

Enrollment Goal
11
Trial Dates
May 2015 - July 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987516
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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.
    date_rangeTime Frame:
    16-24 hours post exposure
    enhanced_encryption
    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
1

Additional Information

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