NCT02751515

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

April 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

April 22, 2016

Last Update Submit

July 25, 2016

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)

Bain De Soliel - Solid

EXPERIMENTAL

All subjects are patched with the same product

Other: Bain De Soliel - SolidOther: Untreated skin

Interventions

Bain De Soliel - SolidOTHER

0.05gm/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.

Bain De Soliel - Solid
Untreated skinOTHER

One site is patched without treatment as control

Bain De Soliel - Solid

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 Health Insurance Portability and Accountability (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 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 Contract Research Organization (CRO) 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
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 26, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(1)