Human Photoallergy Test

NCT02750449 | Completed

• 1 other identifier: 18852
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the potential of a test material to produce a photo allergic response.

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Intensity of skin reactions is evaluated by 5 point grading scale

  Up to 72 hours

Study Arms (1)

Arm 1

EXPERIMENTAL

All subjects are patched.

Drug: Sun screening Sport Lotion, (BAY987516); Other: Untreated skin

Interventions

Sun screening Sport Lotion, (BAY987516) DRUG

50 μl/ cm\*2 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 3 μl/ 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. 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 - RB# Y65-110)

Arm 1

Untreated skin OTHER

This site is patched without treatment as control

Arm 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 Act (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 CRO and/or Bayer or is a household member of an employee;

Sponsors & Collaborators

• Bayer: lead

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
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 25, 2016
• Study Start: May 9, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)