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

Sun Protection Clinical Trial

— PFA and SPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001975
• Other study ID #: 18119
• Secondary ID: SR09-15P08236
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2009
• Last updated: February 20, 2015
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sun Protection

Intervention

Drug:
• Sunscreen Test Code: V53-028
Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
• Sunscreen Test Code: V53-030
Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone
• Standard SPF 4 Sunscreen
8% Homosalate Standard SPF 4 Sunscreen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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