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OpenTrials
Completed

NCT Number: NCT02995148

Sun Protection Factor Assay (343/2016)

To evaluate the Sun Protection Factor efficacy on human skin.

Completed

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Key information

Conditions

Sunscreening Agents

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union, New Jersey, 07083, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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 diagnosed 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.

Treatment and study plan

BAY987521

Drug

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: Z43-104)

SPF Control

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2016
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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