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

Determination of Sun Protection Factors (PFA and SPF) in Sunscreen Formulas Containing Combinations of Zinc Oxide and Avobenzone

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.

Study Overview

• Status: Completed
• Conditions: Sun Protection
• Intervention / Treatment: Drug: Sunscreen Test Code: V53-028; Drug: Sunscreen Test Code: V53-030; Drug: Standard SPF 4 Sunscreen

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Sunscreen Test Code: V53-028; Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole; Drug: Sunscreen Test Code: V53-030; Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone; Drug: Standard SPF 4 Sunscreen; 8% Homosalate Standard SPF 4 Sunscreen
Experimental: 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.	Drug: Sunscreen Test Code: V53-028; Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole; Drug: Sunscreen Test Code: V53-030; Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Sunscreen Protection Factor (SPF)	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).	16 to 24 hours post-exposure
Determination of Ultraviolet A Protection Factor (PFA)	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).	2 to 4 hours post-exposure

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Sunscreens
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 18119 (Other Identifier: City of Hope Comprehensive Cancer Center); SR09-15; P08236 (Other Identifier: Merck)