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

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.

Completed

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Key information

Conditions

Sun Protection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunscreen Test Code: V53-028

Drug

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

Sunscreen Test Code: V53-030

Drug

Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

Standard SPF 4 Sunscreen

Drug

8% Homosalate Standard SPF 4 Sunscreen

Primary outcomes

Determination of Sunscreen Protection Factor (SPF)

Time frame: 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)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PFA and SPF

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Oct 27, 2009
Registry last updated: Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed