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Human Photoallergy Test

NCT ID: NCT02750449

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-09

Study Completion Date

2016-07-01

Brief Summary

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

Detailed Description

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Conditions

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Sunscreening Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

All subjects are patched.

Group Type EXPERIMENTAL

Sun screening Sport Lotion, (BAY987516)

Intervention Type 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)

Untreated skin

Intervention Type OTHER

This site is patched without treatment as control

Interventions

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Sun screening Sport Lotion, (BAY987516)

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)

Intervention Type DRUG

Untreated skin

This site is patched without treatment as control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Piscataway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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18852

Identifier Type: -

Identifier Source: org_study_id