Human Phototoxicity Test

Sunscreening Agents Clinical Trial

Official title:

Human Phototoxicity Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751489
• Other study ID #: 18600
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: June 16, 2016
• Start date: May 2016
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: 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: May 2016
• Est. primary completion date: May 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 (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

Study Design

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

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Sunscreening Agents

Intervention

Other:
• Bain De Soliel - Solid
0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.

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 is evaluated by 5 point scale		Up to 48 hours	Yes

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