Sun Protection
Conditions
Keywords
Sunscreens
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.
Interventions
DRUGSunscreen Test Code: V53-028
Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
DRUGSunscreen Test Code: V53-030
Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone
DRUGStandard SPF 4 Sunscreen
8% Homosalate Standard SPF 4 Sunscreen
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sun Protection Factor (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 Radiation A \[UVA\] and ultraviolet radiation B \[UVB\]). | 5 |
| 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Sun Protection Factor (SPF) Testing | UVA Protection Testing | Total |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 9.8 | 38 years STANDARD_DEVIATION 12.6 | 40.3 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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).
Time frame: 16 to 24 hours post-exposure
Population: Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sun Protection Factor (SPF) Testing | Determination of Sunscreen Protection Factor (SPF) | V53-028 | 14.72 Score on a scale | Standard Deviation 2.31 |
| Sun Protection Factor (SPF) Testing | Determination of Sunscreen Protection Factor (SPF) | V53-030 | 15.00 Score on a scale | Standard Deviation 0 |
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).
Time frame: 2 to 4 hours post-exposure
Population: Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UVA Protection Testing | Determination of Ultraviolet A Protection Factor (PFA) | V53-028 | 11.60 Score on a scale | Standard Deviation 2.01 |
| UVA Protection Testing | Determination of Ultraviolet A Protection Factor (PFA) | V53-030 | 10.50 Score on a scale | Standard Deviation 1.12 |