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The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.
This study consist of two steps. Step 1: determination of the SPF of the test products which will be performed as a single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study as per ISO24444:2010. And Step 2: determination of the UVAPF of the test products which will be performed as a single center, open-label, negative and positive controlled technical test as per ISO24443:2012 (using test plates for assessing UV transmittance of four developmental sunscreens).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference product (for SPFi calculation) | Active Comparator | This arm will include all the test sites on the participants back where reference product (P3 standard sunscreen) will be applied. |
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| Test product 1 | Experimental | This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 1 will be applied for SPF testing. |
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| Test product 2 | Experimental | This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 2 will be applied for SPF testing. |
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| Test product 3 | Experimental | This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 3 will be applied for SPF testing. |
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| Test product 4 | Experimental | This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 4 will be applied for SPF testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGBUV000A, (Expected SPF 30) | Other | A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates. |
| Measure | Description | Time Frame |
|---|---|---|
| Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection. | Up to 24 hours post UV exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Spectrum of Sun Protection | Broad spectrum of sun protection was calculated by the ratio of the arithmetic mean of SPF to the arithmetic mean of UVAPF. Higher values represents increased SPF protection. | Up to 30 minutes post UV exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Schenefeld | Schleswig-Holstein | 22869 | Germany |
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Total of 9 participants were screened for the study out of which 1 participant did not meet the study criteria. Remaining 8 participants were randomized in the study.
All the participants were enrolled at one center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All the participants randomized to the study. In this study, there were a total of 7 test sites assigned to each participant. One test site was used for provisional MEDu (Minimal Erythemal Dose of Unprotected Skin) measurement, on the remaining 6 sites test products (4) and the positive control product (P3 standard) were applied and 1 site was left unprotected. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2017 | Jun 14, 2018 |
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| Negative control (for SPFi calculation) | No Intervention | This arm will include all the test sites on the participants back which will be left unprotected. |
| Reference (for UVAPFi calculation) | Active Comparator | This arm will include test plates treated with reference sunscreen formulation S2. |
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| Blank control (for UVAPFi calculation) | Other | This arm will include blank test plates treated with glycerin. |
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| NGBUV000B, (Expected SPF 30) | Other | A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates. |
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| NGBUV000C, (Expected SPF 30) | Other | A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates. |
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| NGBUV000D, (Expected SPF 30) | Other | A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates. |
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| P3 Standard, (Expected SPF 16) | Other | A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant. |
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| Sunscreen formulation S2 | Other | A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates. |
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| Glycerin | Other | A total of 1.3 mg/cm2 of glycerin will be applied to the test plates. |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline parameters were reported for safety population (N=8). The Safety population included all participants who applied any of the study products.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Included all the participants who randomized to receive the study product. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection. | Analysis population included all randomized participants who underwent irradiation at Visit 4. Here, number analyzed signifies participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | Ratio | Up to 24 hours post UV exposure |
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| Secondary | Spectrum of Sun Protection | Broad spectrum of sun protection was calculated by the ratio of the arithmetic mean of SPF to the arithmetic mean of UVAPF. Higher values represents increased SPF protection. | Analysis population included all randomized participants who underwent irradiation at Visit 4. | Posted | Number | Ratio | Up to 30 minutes post UV exposure |
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Approximately 16 days
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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 | Reference Product (for SPFi Calculation) | This arm included all the test sites on the participants back where reference product (P3 standard sunscreen) was applied. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Negative Control (for SPFi Calculation) | This arm included all the test sites on the participants back which were left unprotected. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Test Product 1 | This arm included all the test sites on the participants back where test product 1 was applied for SPF testing. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Test Product 2 | This arm included all the test sites on the participants back where test product 2 was applied for SPF testing. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | Test Product 3 | This arm included all the test sites on the participants back where test product 3 was applied for SPF testing. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | Test Product 4 | This arm included all the test sites on the participants back where test product 4 was applied for SPF testing. | 0 | 8 | 0 | 8 | 0 | 8 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2017 | Jun 14, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG004 | Reference (for UVAPFi and SPFi Calculation) | This arm included test plates treated with reference sunscreen formulation S2. Also includes all the test sites on the participants back where reference product (P3 standard sunscreen) was applied. |
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