NCT02831478

Brief Summary

To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1 day

First QC Date

July 11, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreening Agent

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

BAY987517DRUG

Applied liberally to the skin (Formulation: RB# Z16-071)

BAY987517
Sunscreen Lotion (RB# T78-190B)DRUG

Applied liberally to the skin

Sunscreen Lotion

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

July 9, 2016

Primary Completion

July 10, 2016

Study Completion

July 10, 2016

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)