This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED) (NCT01001975), a non-randomized phase 3 study. The primary outcome is Determination of Sunscreen Protection Factor (SPF).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01001975 |
| Phase | Phase 3 |
| Condition | Sun Protection |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 10 participants across separate SPF Testing and UVA Protection Testing groups. The registry record does not report further participant characteristics or eligibility details.
Intervention
The study evaluated sunscreen test materials V53-028 and V53-030. The official title describes sunscreen formulas containing combinations of zinc oxide and avobenzone; the brief summary notes formulations with and without ensulizole. The record does not map each ingredient combination to a test code.
Comparator
The SPF endpoint description identifies 8% Homoslate SPF 4 as a control test material. A standard SPF 4 sunscreen is also listed among the interventions. The record does not describe a randomized allocation of products or establish that the SPF and UVA groups are directly comparable.
Primary question
The primary question was how the test materials scored on the sunscreen protection factor scale after controlled ultraviolet exposure. SPF was defined using the ratio of the minimal erythema dose on protected skin to that on unprotected skin. Separately, the study description identifies UVA protection factor, or PFA, testing based on pigmentation responses after UVA exposure. Numerical outcome results are not reported in the registry record, so the record cannot establish the observed SPF or PFA for either test material.
3. Trial Design
This completed Phase 3 study, sponsored by Bayer, is listed as a non-randomized, single-masked, parallel study with an enrollment of 10. Its registry title concerns the determination of protection factors in sunscreen formulas containing combinations of zinc oxide and avobenzone. The brief summary distinguishes products with and without ensulizole. The record does not specify which test code corresponds to which ingredient combination.
Participants were assigned to SPF Testing or UVA Protection Testing groups, with 5 participants at risk listed for each group in the adverse-event record. The SPF endpoint description says that only subjects from the SPF Testing group had V53-028 and V53-030 applied for SPF determination. The two groups therefore represent different testing procedures, not randomized treatment arms intended for a like-for-like comparison. The record explicitly flags the allocation as non-randomized and cautions that the arms are not a like-for-like control comparison.
The SPF procedure involved test materials and a control applied to test areas, followed by a series of ultraviolet light exposures. Protected and unprotected skin were assessed to determine minimal erythema dose, with SPF calculated from those doses. The listed SPF assessment time was 16 to 24 hours post-exposure. For UVA protection, the record describes UVA-exposed sites assessed for pigmentation responses 2 to 4 hours post-exposure. The listed interventions also include a standard SPF 4 sunscreen.
The study began in 2009-07, reached primary completion in 2009-08, and is marked completed. Detailed eligibility criteria, masking procedures, allocation procedures, and the rationale for enrollment are not reported in the registry record. No numerical protection-factor results or statistical outcome analyses are reported.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Sun Protection Factor (SPF) Testing | UVA Protection Testing |
|---|---|---|
| STARTED | 5 | 5 |
| COMPLETED | 5 | 5 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Sun Protection Factor (SPF) Testing | UVA Protection Testing | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 5 | 10 | |
| Age, Continuous | years | 42.6 (SD 9.8) | 38 (SD 12.6) | 40.3 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 4 | 4 | 8 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Determination of Sunscreen Protection Factor (SPF), measured over 16 to 24 hours post-exposure.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the determination of sunscreen protection factor, or SPF, reported as a mean score on a scale with standard deviation as the stated measure of spread. SPF is based on the minimal erythema dose, or MED: the exposure dose associated with an erythema response. The registry description says SPF was calculated as the MED of protected skin divided by the MED of unprotected skin after a series of ultraviolet light exposures. Assessment was listed for 16 to 24 hours post-exposure.
SPF is used to express protection against the erythema response under the specified testing conditions. It provides a single summary of the relationship between protected and unprotected test sites, rather than a direct account of every participant’s response. The registry description gives an expected SPF 15 and a scale range from 11.34 (worst) to 19.83 (best). These are stated as expected scale information, not as observed study results.
The endpoint description identifies V53-028 and V53-030 as test materials and 8% Homoslate SPF 4 as the control test material. It also says that only the SPF Testing group had the two test materials applied for SPF determination. The registry record does not report the mean SPF, standard deviation, participant-level values, or an estimate comparing products. The outcome measure count is 2, but numerical results for the primary endpoint are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study question and the procedures used to assess sunscreen protection, but it does not report numerical outcome results. There are no posted mean SPF scores, standard deviations, confidence intervals, or statistical tests. As a result, the reported information does not show the observed SPF for either test material, the variability among participants, or the precision of any estimated difference. The record also gives no numerical PFA results.
The stated expected SPF 15 and the scale range from 11.34 (worst) to 19.83 (best) are endpoint-scale information in the description. They should not be read as observed findings from this study. The registry record does not say what mean score was actually obtained, how individual values were distributed, or whether a test material differed from the control. No numerical conclusion about the performance of one formulation relative to another can be drawn from the record.
The design matters for interpretation. Allocation is listed as non-randomized, and the record cautions that the arms are not a like-for-like control comparison. The SPF Testing and UVA Protection Testing groups underwent different assessments, and only SPF Testing participants had the two named test materials applied for SPF determination. Consequently, the separate testing groups do not support a direct randomized comparison between SPF and UVA protection. Nor does the record establish a randomized comparison of the sunscreen test materials against the control.
The enrollment was 10, and the adverse-event listing shows 5 participants at risk in each of the two testing groups. That small study size limits how much can be inferred about response variation or uncommon events, even if numerical results were available. Because the outcome analyses are not reported, there is no basis in the registry record to assess uncertainty around the protection-factor estimates. A mean without a measure of precision would be incomplete for judging how reliably it characterizes the tested participants; here, even those mean results are absent.
The completed status indicates that the study is marked completed in the registry; it does not supply missing endpoint findings. The record lists 2 outcome measures and 0 analyses. It therefore documents a planned measurement framework and testing procedures, rather than a results-based estimate of SPF or PFA. Any interpretation should be limited to those record details and should not treat the expected scale value as evidence of what the study observed.
9. Statistical Methods Explained
The registry record identifies a continuous primary outcome summarized as a mean with standard deviation. That description tells readers how the outcome was intended to be presented, but not what values were obtained. The mean is a measure of the average score in the analyzed observations. The standard deviation describes how spread out individual measurements are around that average. These quantities answer different questions: a mean describes the central score, while a standard deviation describes participant-to-participant variation. Neither is reported numerically for the primary endpoint in the registry record.
What does the SPF calculation represent?
The endpoint description defines SPF using the minimal erythema dose on protected skin relative to the minimal erythema dose on unprotected skin. In general, a ratio of this kind compares the exposure associated with a specified response across protected and unprotected test sites. The record describes a series of ultraviolet exposures followed by scoring of erythema responses, with assessments 16 to 24 hours after exposure. It does not report the underlying MED values, participant-level SPF values, or the method used to combine multiple observations into a group summary beyond specifying a mean and standard deviation.
The record also refers to FDA guidelines for the SPF testing procedure. That reference describes the stated testing context; the registry entry does not provide a full protocol or enough detail to reconstruct every operational step. The described control material was 8% Homoslate SPF 4. V53-028 and V53-030 were the test materials, but the posted record does not give product-specific numerical results or a statistical contrast with the control.
How should a confidence interval be understood?
In general, a confidence interval communicates the precision of an estimate by giving a range of values compatible with the data and the interval method. A narrower interval indicates greater precision under the chosen method and assumptions; a wider interval indicates less precision. A confidence interval does not report the spread of individual participant measurements, which is what the standard deviation describes. The registry record does not report confidence intervals for SPF or PFA, so the precision of any protection-factor estimate cannot be evaluated from the posted results.
What can the design establish?
The study is listed as non-randomized and parallel, with separate SPF Testing and UVA Protection Testing groups. Random allocation can, in general, help balance prognostic factors across comparison groups. Without randomized allocation, group differences can reflect differences in participants, procedures, or other factors as well as any product-related contrast. Here, the record additionally states that the groups are not a like-for-like control comparison. The SPF and UVA groups assess different outcomes under different exposure and scoring procedures; they should not be treated as interchangeable arms in a comparative estimate.
The study is single-masked, but the record does not describe who was masked or how masking was maintained. It is not possible to infer from the masking label alone which sources of measurement or assessment bias were addressed. The record also does not explain how participants were allocated to testing groups, whether all enrolled participants were included in endpoint summaries, or how missing measurements were handled.
Why do dispersion and analysis details matter?
Standard deviation is a descriptive measure of the observed spread, not a direct measure of the uncertainty in a group mean. General statistical methods may use sample size and variability to estimate the uncertainty of a mean or a difference. Those calculations also depend on the analysis population, data structure, and assumptions. The registry record provides no mean, standard deviation, confidence interval, or numerical analysis for the outcome, and it does not report an inferential model or test. There is therefore no posted estimate to interpret or recalculate.
Some continuous outcomes can show more variability than a simple model expects, a general issue called over-dispersion in settings where it applies. It matters because a model that understates variability can produce overly precise uncertainty estimates. The record does not provide enough outcome data or model detail to assess whether over-dispersion is relevant to these protection-factor measurements. No distributional assessment or adjustment is reported in the registry record.
The registry record notes 0 analyses. It does not report an analysis plan, adjustment factors, hypothesis tests, interim analyses, or a sample-size justification. General planning illustrations based on a study effect are not equivalent to a prospective design justification or observed power, and no numerical planning results are reported in the record details. In the absence of an analysis and outcome estimates, statistical significance, precision, and comparative magnitude cannot be assessed. The methods information supports understanding what was measured, but it does not support a quantitative conclusion about the results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 2 outcome measures and 0 analyses. It does not report the full set of outcome results, the relationship between the outcome measures, or a statistical analysis plan. Although SPF is identified as the primary endpoint and the study description also discusses PFA, the record does not provide numerical estimates for either measure. It is therefore not possible to determine whether multiple endpoints, products, or comparisons were tested in the analysis or whether any multiplicity adjustment was planned or used.
In general, multiplicity arises when multiple hypotheses or outcomes are examined; without an appropriate plan, the chance of obtaining an apparently notable result by chance can increase. The registry entry does not report whether this issue was addressed. It also does not state whether an interim analysis was conducted. Interim analyses, multiplicity procedures, and the statistical plan are not reported in the registry record.
The entry does not describe missing-data handling, participant exclusions, or the analysis population for the endpoint. It does not indicate how many participants contributed usable SPF or PFA measurements, whether all enrolled participants were analyzed, or how incomplete test measurements were treated. The adverse-event record lists 5 participants at risk in each testing group, but that listing does not establish the number included in each efficacy analysis. The absence of these details makes it impossible to assess how missing observations or analysis-population choices may have affected reported estimates. No numerical endpoint analyses are reported against which those choices could be evaluated.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sun Protection Factor (SPF) Testing | 0 | 5 | 0.0% |
| UVA Protection Testing | 0 | 5 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sun Protection Factor (SPF) Testing | 0 of 5 |
| UVA Protection Testing | 0 of 5 |
The adverse-event listing shows 0 serious adverse events among 5 participants at risk in the SPF Testing group and 0 among 5 participants at risk in the UVA Protection Testing group. It also shows 0 other adverse events among 5 participants at risk in each group. Deaths are not reported in the registry record.
These figures describe the entries in the registry record for the listed groups. A zero count means that no events of that category are recorded for the participants at risk in that listing; it does not establish that an event could not occur or rule out events that were not captured or reported. The enrollment was 10, and the at-risk counts are 5 per group. The record does not provide event definitions beyond the serious and other categories, follow-up details for safety, or a narrative describing how events were collected and assessed.
The study groups were assigned to different testing procedures, not to randomized, like-for-like safety comparisons. The counts should therefore not be treated as a randomized comparison between products or testing groups. With few participants listed at risk and no further safety detail, the record offers only a limited description of reported events. It does not provide a basis for estimating a broader event frequency or comparing safety across formulations.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed study was designed to assess sunscreen protection factors using two testing procedures. The primary endpoint was an SPF score based on protected and unprotected skin responses after ultraviolet exposure. The study description also identifies UVA protection factor testing based on pigmentation responses. It records test materials V53-028 and V53-030, a control material described as 8% Homoslate SPF 4, and a standard SPF 4 sunscreen intervention.
It does not establish the observed SPF or PFA for any product. No numerical outcome results, group means, standard deviations, confidence intervals, or inferential analyses appear in the registry record. The expected SPF 15 and the stated scale range from 11.34 (worst) to 19.83 (best) are descriptions of the expected score and scale, not the study's observed findings. They cannot substitute for the missing outcome estimates.
The design information also limits comparative interpretation. The study was non-randomized, and the registry record warns that the arms are not a like-for-like control comparison. SPF Testing and UVA Protection Testing involved different endpoints and procedures. The record does not report a randomized product comparison or a numerical estimate of the difference between test materials and control. A claim that one formulation performed better or worse is therefore unsupported by the posted results.
The safety listing records no serious or other adverse events among the 5 participants at risk in each testing group, while deaths are not reported in the registry record. These entries are descriptive and based on a small enrollment; they do not establish broader safety rates. The record's completed status confirms study status only. Overall, it documents the measurement framework and selected design features, but leaves the efficacy estimates, their precision, and detailed analysis methods unavailable.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the difference between a protocol-like description and a results record. It specifies a protection-factor question, identifies the SPF measurement scale, and describes how protected and unprotected test sites were used to derive SPF. It also distinguishes SPF testing from UVA protection testing. Those details help define what the endpoint was intended to represent, even though the numerical results are absent.
The record also illustrates why design labels matter. Non-randomized allocation and distinct testing groups do not support the same interpretation as a randomized, like-for-like product comparison. The registry explicitly cautions against treating the arms as a direct control comparison. For a statistical reader, this means that the design cannot be summarized as a conventional randomized comparison of the test materials and control based on the information posted.
Another important issue is the separation of a scale description from an observed result. The expected SPF 15 and stated range from 11.34 (worst) to 19.83 (best) are not group estimates. A complete quantitative interpretation would require observed values and an account of their uncertainty. The registry record reports neither for SPF or PFA. This prevents assessment of the magnitude and precision of the outcomes and makes it inappropriate to infer an effect from the scale information alone.
Finally, the entry shows how limited safety counts can be in a small study. It lists no serious or other adverse events in the at-risk counts, but does not include detailed follow-up or event-collection methods. Taken together, the study record is useful for understanding the measurement framework and its interpretive constraints. It is not a numerical demonstration of comparative sunscreen performance.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation is that numerical outcome results are not reported in the registry record. Although the primary SPF endpoint is described as a mean with standard deviation, neither statistic is posted. No PFA result, confidence interval, participant-level data, or inferential analysis is reported. This prevents evaluation of observed protection-factor values, variability, precision, or differences between test materials.
The enrollment was 10, with 5 participants at risk in each testing group. This is a small study population for characterizing variation or uncommon events. The record does not provide participant characteristics, eligibility criteria, or enough detail to judge how representative the enrolled participants were of other populations. It also does not report how many participants contributed outcome data or whether measurements were missing.
Allocation was non-randomized. The registry record cautions that the arms are not a like-for-like control comparison. The SPF and UVA groups had different testing procedures, and the record states that only the SPF Testing group had V53-028 and V53-030 applied for SPF determination. The study description does not support treating those groups as randomized comparison arms. The ingredient combinations are described in general, but their mapping to test codes is not reported in the registry record.
Further details about allocation, masking, endpoint scoring, analysis populations, missing-data handling, statistical methods, multiplicity, interim analyses, and sample-size justification are not reported in the registry record. The single-masked label is not accompanied by an explanation of who was masked. The absence of these details limits assessment of potential bias and the analysis choices. Safety reporting is also limited to event counts, without further information about event definitions, collection, or follow-up.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED) — NCT01001975.
- Registry record last updated 2015-03-11; status last verified 2015-02.
- Results first posted 2010-12-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01001975 is a completed Phase 3, non-randomized, single-masked, parallel study sponsored by Bayer. The registry lists enrollment of 10 and describes SPF Testing and UVA Protection Testing groups. The study assessed sunscreen formulas described as containing combinations of zinc oxide and avobenzone, with and without ensulizole, using test codes V53-028 and V53-030. The primary endpoint was a mean SPF score with standard deviation, calculated from protected and unprotected skin responses after ultraviolet exposure. The study description also includes PFA testing.
The record lists a control material of 8% Homoslate SPF 4 and a standard SPF 4 sunscreen. It cautions that the non-randomized arms are not a like-for-like control comparison. Numerical endpoint results and analyses are not reported in the registry record. Adverse-event listings show 0 serious and 0 other events among 5 participants at risk in each testing group; deaths are not reported in the registry record.