18348-Human Phototoxicity Test

Sunscreening Agents Clinical Trial

Official title:

Human Phototoxicity Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823483
• Other study ID #: 18348
• Status: Completed
• Phase: N/A
• First received: July 1, 2016
• Last updated: July 1, 2016
• Start date: November 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA:Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine the phototoxic potential of a topically applied article in human subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• 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 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 dermatosis;

• must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.

• have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Sunscreening Agents

Intervention

Other:
• Sunscreen Lotion (BAY987521)
50 µl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.Formulation A: Y49-103, Formulation B: Y71-150.
• Untreated Skin
This site is patched without treatment as irradiated control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of skin reactions will be evaluated using the 5 point		Up to 48 hours	Yes

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