Outdoor-Use Test for Sunscreen Products in Children Ages... | NCT02831478

Studies
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

NCT02831478

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 12, 2018Actual

Enrollment

98Actual

Phase

Not Applicable

Conditions

Sunscreening Agent

Interventions

BAY987517
Sunscreen Lotion (RB# T78-190B)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2016Actual

Primary Completion Date

Jul 10, 2016Actual

Completion Date

Jul 10, 2016Actual

First Submitted Date

Jul 11, 2016

First Submission Date that Met QC Criteria

Jul 11, 2016

First Posted Date

Jul 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2018

Last Update Posted Date

Dec 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAY987517	Experimental	2/3 of subjects testing the test article	Drug: BAY987517
Sunscreen Lotion	Active Comparator	1/3 of subjects testing the marketed control	Drug: Sunscreen Lotion (RB# T78-190B)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY987517	Drug	Applied liberally to the skin (Formulation: RB# Z16-071)	BAY987517

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3		From the beginning of the study until 24 hours after study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
Subjects must have Fitzpatrick Skin Type I, II, III or IV.
Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria:

Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
Subjects must not have significantly tanned skin.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		St. Petersburg	Florida	33714	United States