18776 - Human Photoallergy Test

Sunscreening Agents Clinical Trial

Official title:

Human Photoallergy Test

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02751567
• Other study ID #: 18776
• Status: Withdrawn
• Phase: N/A
• First received: April 22, 2016
• Last updated: May 20, 2016
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Other:
• BAY987516
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.
• Untreated skin
One site is patched without treatment as control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of skin reactions is evaluated by 5 point scale		Up to 72 hours	Yes

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