- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02823496
18349-Human Photoallergy Test
July 1, 2016 updated by: Bayer
Human Photoallergy Test
To evaluate the potential of a test material to produce a photoallergic response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08854
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
All subjects are patched with the same product
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One site is patched without treatment as control
50 μl/ 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.
Formulation A: Y49-103, Formulation B: Y71-150.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intensity of skin reactions is evaluated by 5 point scale
Time Frame: Up to 72 hours
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Up to 72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 1, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (Estimate)
July 6, 2016
Study Record Updates
Last Update Posted (Estimate)
July 6, 2016
Last Update Submitted That Met QC Criteria
July 1, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity
- Dermatitis
- Skin Diseases, Eczematous
- Hypersensitivity, Delayed
- Dermatitis, Contact
- Photosensitivity Disorders
- Dermatitis, Allergic Contact
- Dermatitis, Photoallergic
- Physiological Effects of Drugs
- Protective Agents
- Dermatologic Agents
- Radiation-Protective Agents
- Sunscreening Agents
Other Study ID Numbers
- 18349
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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