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Sun Protection Factor (SPF) Efficacy Assay

NCT ID: NCT02885805

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

2015-06-26

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 + Control

Fair-skinned subjects in good health with Skin Types I, II or III.

Group Type EXPERIMENTAL

BAY987516

Intervention Type DRUG

2.00 mg/cm2 ± 0.04 mg/cm2

SPF 15 Control

Intervention Type DRUG

2.00 mg/cm2 ± 0.04 mg/cm2

Interventions

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BAY987516

2.00 mg/cm2 ± 0.04 mg/cm2

Intervention Type DRUG

SPF 15 Control

2.00 mg/cm2 ± 0.04 mg/cm2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing.
* Sex: Male or female.
* Age: 18-70 years.
* Good health as determined from the HRL SHF.
* Signed and dated lnformed Consent Form.
* Signed and dated HIPAA Form.
* An unambiguous MED or MPPD
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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18322

Identifier Type: -

Identifier Source: org_study_id