NCT02823483

Brief Summary

To determine the phototoxic potential of a topically applied article in human subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

July 1, 2016

Last Update Submit

July 1, 2016

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

  • Intensity of skin reactions will be evaluated using the 5 point

    Up to 48 hours

Study Arms (1)

Arm 1

EXPERIMENTAL

All subjects are patched.

Other: Sunscreen Lotion (BAY987521)Other: Untreated Skin

Interventions

Sunscreen Lotion (BAY987521)OTHER

50 μl/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.Formulation A: Y49-103, Formulation B: Y71-150.

Arm 1
Untreated SkinOTHER

This site is patched without treatment as irradiated control

Arm 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be male or female between the ages of 18 and 60 inclusive;
  • be lightly pigmented (Fitzpatrick Skin Type I, II, III);
  • have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
  • be in general good health as determined by the subject's medical history and in the discretion of the investigator;

You may not qualify if:

  • have a visible sunburn;
  • have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
  • must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
  • have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Piscataway, New Jersey, 08854, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 6, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(1)