NCT02741466

Brief Summary

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

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

March 15, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

15 days

First QC Date

April 13, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (2)

  • Minimal Erythema Dose(MED)

    Up to 15 minites

  • Minimal Persistent Pigment Darkening Dose (MPPD)

    Up to 15 minites

Study Arms (1)

BAY987517

EXPERIMENTAL

Each test site area is divided into test subsite areas that are approximately at least 0.5 cm\*2. The application of test material is 2 mg/cm\*2. Thus, each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application

Drug: Coppertone (BAY987517)

Interventions

Coppertone (BAY987517)DRUG

Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application. Formulation number - SR16-01.

BAY987517

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
  • Male or female
  • Aged between 18-70 years old.
  • Good health
  • Signed and dated Informed Consent Form
  • Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form
  • An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

You may not qualify if:

  • Subjects on test at any other research laboratory or clinic.
  • Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
  • PRe-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
  • Pre-existing other medical conditions (e.g. adult asthma. diabetes).
  • Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
  • Treatment with antibiotics within two weeks prior to initiation of the test
  • Chronic medication which could affect the results of the study.
  • Known pregnant or nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Union, New Jersey, 07083, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 18, 2016

Study Start

March 15, 2016

Primary Completion

March 30, 2016

Study Completion

March 30, 2016

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

US(1)