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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01001975
• Collaborator: (none)
• Enrollment: 10
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sun Protection	Drug: Sunscreen Test Code: V53-028; Drug: Sunscreen Test Code: V53-030; Drug: Standard SPF 4 Sunscreen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Determination of Sun Protection Factors (PFA and SPF) in Sunscreen Formulas Containing Combinations of Zinc Oxide and Avobenzone
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01001975
• Other Study ID Numbers: 18119; SR09-15; P08236
• First Posted: Oct 27, 2009
• Last Update Posted: Mar 11, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Bayer: Sunscreens
• Additional relevant MeSH terms: Sunscreening Agents

Study Results

Participant Flow

Arm/Group Title	Sun Protection Factor (SPF) Testing	UVA Protection Testing
Arm/Group Description	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 Radiation A [UVA] and ultraviolet radiation B [UVB]).	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.
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sun Protection Factor (SPF) Testing	UVA Protection Testing	Total
Arm/Group Description	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 Radiation A [UVA] and ultraviolet radiation B [UVB]).	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.	Total of all reporting groups
Overall Participants	5	5	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.6 (9.8)	38 (12.6)	40.3 (11.2)
Sex: Female, Male (Count of Participants)
Female	4 80%	4 80%	8 80%
Male	1 20%	1 20%	2 20%

Outcome Measures

1. Primary Outcome

Title	Determination of Sunscreen Protection Factor (SPF)
Description	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).
Time Frame	16 to 24 hours post-exposure

Outcome Measure Data

Analysis Population Description

Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF

Arm/Group Title	Sun Protection Factor (SPF) Testing	UVA Protection Testing
Arm/Group Description	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 Radiation A [UVA] and ultraviolet radiation B [UVB]).	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.
Measure Participants	5	0
V53-028	14.72 (2.31)
V53-030	15.00 (0.00)

2. Primary Outcome

Title	Determination of Ultraviolet A Protection Factor (PFA)
Description	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).
Time Frame	2 to 4 hours post-exposure

Outcome Measure Data

Analysis Population Description

Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA

Arm/Group Title	Sun Protection Factor (SPF) Testing	UVA Protection Testing
Arm/Group Description	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 Radiation A [UVA] and ultraviolet radiation B [UVB]).	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.
Measure Participants	0	5
V53-028	11.60 (2.01)
V53-030	10.50 (1.12)

Adverse Events

Arm/Group Title	Sun Protection Factor (SPF) Testing		UVA Protection Testing
Arm/Group Description	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 Radiation A [UVA] and ultraviolet radiation B [UVB]).		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.
All Cause Mortality
	Sun Protection Factor (SPF) Testing		UVA Protection Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sun Protection Factor (SPF) Testing		UVA Protection Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Sun Protection Factor (SPF) Testing		UVA Protection Testing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that no information based on the conduct (including the protocol, the data resulting from this study or the fact that this study is being conducted) will be released without prior written consent of the sponsor, unless this requirement is superceded by the State or Federal law.