Sun Protection Factor Assay

NCT ID: NCT02803021

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-29

Study Completion Date

2015-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the Sun Protection Factor efficacy on human skin.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sunscreening Agent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BAY987517

Each test site area is divided into test subsite 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.

Group Type EXPERIMENTAL

Coppertone (BAY987517)

Intervention Type 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 Number - SR15-47-Z13-076)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coppertone (BAY987517)

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 Number - SR15-47-Z13-076)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unbAmbiguous 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Union, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18630

Identifier Type: -

Identifier Source: org_study_id