Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED) (PFA and SPF)

Bayer

Status and phase: Completed; Phase 3

Conditions: Sun Protection

Treatments: Drug: Standard SPF 4 Sunscreen; Drug: Sunscreen Test Code: V53-028; Drug: Sunscreen Test Code: V53-030

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001975

18119

P08236 (Other Identifier)

SR09-15

Details and patient eligibility

About

Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 70 years of age
• Have Fitzpatrick skin types I, II, or III
• In good general health based on a medical history review
• Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
• Be able to cooperate with the investigator and research staff
• Be willing to have the test materials applied according to the protocol
• Be capable of understanding and provide written informed consent

Exclusion criteria

• Subjects with a history of adverse effects upon sun exposure
• Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
• Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
• Subjects with an abnormal sensitivity to any sunscreen agent
• Females who indicate that they are pregnant or nursing an infant during the period of the study
• Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or uneven pigmentation in the test areas
• Subjects who have been administered an investigations drug or have participated in another SPF or PFA study within 30 days prior to this study
• Subjects who are allergic to latex or latex products
• Subjects who have any conditions that would make study participation inappropriate as determined by the investigator

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups

SPF Testing

Experimental group

Description:

Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation \[UVB\] and UVA).

Treatment:

Drug: Sunscreen Test Code: V53-028

Drug: Standard SPF 4 Sunscreen

Drug: Sunscreen Test Code: V53-030

UVA Protection Testing

Experimental group

Description:

Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.

Treatment:

Drug: Sunscreen Test Code: V53-028

Drug: Sunscreen Test Code: V53-030