Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay

NCT ID: NCT02872246

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-26

Study Completion Date

2015-07-01

Brief Summary

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Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Detailed Description

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Conditions

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Sunscreen Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SPF evaluation

Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.

Group Type EXPERIMENTAL

BAY 987516

Intervention Type DRUG

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

SPF 15 Control

Intervention Type DRUG

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

Interventions

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BAY 987516

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

Intervention Type DRUG

SPF 15 Control

Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Union, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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18321

Identifier Type: -

Identifier Source: org_study_id