Human Phototoxicity Test

Sunscreening Agents Clinical Trial

Official title:

Human Phototoxicity Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750475
• Other study ID #: 18851
• Status: Completed
• Phase: N/A
• Start date: May 2, 2016
• Est. completion date: May 6, 2016

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• 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: May 6, 2016
• Est. primary completion date: May 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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;

• 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;

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Sunscreening Agents

Intervention

Drug:
• Sunscreen Sport Lotion (BAY987516)
50 µl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) µl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)

Other:
• 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 grading scale		Up to 48 hours

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.