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

Phase 3

Completed

• Conditions: Sun Protection
• Interventions: Drug: Standard SPF 4 Sunscreen

• Registration Number: NCT01001975
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Disposition First Submitted: 2010-07-30
• Disposition First Submitted QC: 2010-07-30
• Disposition First Posted: 2010-08-03
• Results First Submitted: 2010-11-04
• Results First Submitted QC: 2010-11-04
• Results First Posted: 2010-12-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPF Testing	Standard SPF 4 Sunscreen	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).

Primary Outcome Measures

Name	Time	Method
Determination of Sunscreen Protection Factor (SPF)	16 to 24 hours post-exposure	Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).
Determination of Ultraviolet A Protection Factor (PFA)	2 to 4 hours post-exposure	Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).