Sun Protection Factor Assay (317/2016)

NCT02995018 | Completed

• 1 other identifier: 19317
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the Sun Protection Factor efficacy on human skin.

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (2)

• Minimal Erythema Dose (MED)

  Up to 15 minutes

• Minimal Persistent Pigment Darkening Dose (MPPD)

  Up to 15 minutes

Study Arms (1)

SPF evaluation

EXPERIMENTAL

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: BAY987521; Drug: SPF Control

Interventions

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: Z09-174)

SPF evaluation

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.

SPF evaluation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Union, New Jersey, 07083, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: January 3, 2017
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

US (1)