Human Phototoxicity Test

Bayer

Status: Completed

Conditions: Sunscreening Agents

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02751541

18849

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

BAY987519

Experimental group

Description:

All subjects are patched

Treatment:

Other: Untreated Skin

Drug: Sunscreen Sport Spray (BAY987519)