Human Phototoxicity Test

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

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Other: Bain De Soliel - Solid

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854

Participation Criteria

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 (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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bain De Soliel - Solid; All subjects are patched with the same product	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intensity of skin reactions is evaluated by 5 point scale	Up to 48 hours

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Phototoxic
• Other Study ID Numbers: 18600