NCT02962869

Brief Summary

To evaluate the potential of a test material to produce a photoallergic response

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

November 3, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

November 10, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

  • Intensity of skin reactions is evaluated by 5 point scale

    Up to 72 hours

Study Arms (1)

BAY987517

EXPERIMENTAL

All subjects are patched with the same product

Drug: BAY987517Other: Untreated skin

Interventions

BAY987517DRUG

50 μl/ cm\*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm\*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation number: Z43-078)

BAY987517
Untreated skinOTHER

One site is patched without treatment as control

BAY987517

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 (Health Insurance Portability and Accountability Act) 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 dermatoses
  • have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
  • subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee

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
SINGLE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 11, 2016

Study Start

November 3, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

US(1)