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

NCT ID: NCT01001975

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

Conditions

Sun Protection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SPF Testing

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).

Group Type: EXPERIMENTAL

Sunscreen Test Code: V53-028

Intervention Type: DRUG

Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole

Sunscreen Test Code: V53-030

Intervention Type: DRUG

Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

Standard SPF 4 Sunscreen

Intervention Type: DRUG

8% Homosalate Standard SPF 4 Sunscreen

UVA Protection Testing

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.

Group Type: EXPERIMENTAL

Sunscreen Test Code: V53-028

Intervention Type: DRUG

Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole

Sunscreen Test Code: V53-030

Intervention Type: DRUG

Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

Interventions

Sunscreen Test Code: V53-028

Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole

Intervention Type: DRUG

Sunscreen Test Code: V53-030

Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

Intervention Type: DRUG

Standard SPF 4 Sunscreen

8% Homosalate Standard SPF 4 Sunscreen

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SR09-15

Identifier Type: -

Identifier Source: secondary_id

P08236

Identifier Type: OTHER

Identifier Source: secondary_id

18119

Identifier Type: -

Identifier Source: org_study_id