Sun Protection Factor Assay (343/2016)

Sunscreening Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995148
• Other study ID #: 19343
• Status: Completed
• Phase: N/A
• First received: December 14, 2016
• Last updated: February 26, 2018
• Start date: December 30, 2016
• Est. completion date: January 6, 2017

Study information

• Verified date: February 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the Sun Protection Factor efficacy on human skin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 6, 2017
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• BAY987521
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Erythema Dose (MED)		Up to 15 minutes
Primary	Minimal Persistent Pigment Darkening Dose (MPPD)		Up to 15 minutes

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