Human Phototoxicity Test

NCT02751489 | Completed

• 1 other identifier: 18600
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Intensity of skin reactions is evaluated by 5 point scale

  Up to 48 hours

Study Arms (1)

Bain De Soliel - Solid

EXPERIMENTAL

All subjects are patched with the same product

Other: Bain De Soliel - Solid

Interventions

Bain De Soliel - Solid OTHER

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.

Bain De Soliel - Solid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Piscataway, New Jersey, 08854, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 26, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

US (1)