NCT03002922

Brief Summary

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

December 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

10 days

First QC Date

December 19, 2016

Last Update Submit

January 25, 2018

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

  • Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)

    The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner

    At baseline, and post exercise (30 minutes)

Secondary Outcomes (1)

  • Report of eye stinging assessed by questionnaire

    Up to 30 minutes

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams. Subject should sweat profusely.

Drug: BAY987517

Interventions

BAY987517DRUG

Sunscreen formula Y65-158

Healthy subjects

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent.
  • Subjects must sign a written confidentiality agreement including a photography release form.
  • Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.

You may not qualify if:

  • Subjects must not have received or used an Investigational New Drug within the last 30 days.
  • Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33714, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 26, 2016

Study Start

January 18, 2017

Primary Completion

January 28, 2017

Study Completion

January 28, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

US(1)