Human Phototoxicity Test

NCT02751541 | Completed

• 1 other identifier: 18849
• 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 will be evaluated using 5 point grading scale.

  Up to 48 hours

Study Arms (1)

BAY987519

EXPERIMENTAL

All subjects are patched

Drug: Sunscreen Sport Spray (BAY987519); Other: Untreated Skin

Interventions

Sunscreen Sport Spray (BAY987519) DRUG

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#Y51-002)

BAY987519

Untreated Skin OTHER

This site is patched without treatment as irradiated control.

BAY987519

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 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
• Purpose: TREATMENT
• 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 2, 2016
• Primary Completion: May 6, 2016
• Study Completion: May 6, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)