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| ID | Type | Description | Link |
|---|---|---|---|
| SR09-15 | |||
| P08236 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF Testing | Experimental | 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). |
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| UVA Protection Testing | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen Test Code: V53-028 | Drug | Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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]). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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]). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF | Posted | Mean | Standard Deviation | Score on a scale | 16 to 24 hours post-exposure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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]). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharpe & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| 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 |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
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| 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). | Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA | Posted | Mean | Standard Deviation | Score on a scale | 2 to 4 hours post-exposure |
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| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 |
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.