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 Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage (NCT01108523), a na early/phase 1 study. The primary outcome is Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01108523 |
| Phase | EARLY/Phase 1 |
| Condition | Skin Abnormalities |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Healthpoint |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moisture associated skin damage. The condition field also lists Skin Abnormalities. The registry record lists an enrollment of 7, but does not report additional eligibility criteria or a more detailed description of the enrolled participants.
Intervention
HP828-101, described as an experimental formulation and classified as a device. The study evaluated its use in managing moisture associated skin damage over 15 days.
Comparator
There was no separate comparator group. The design is single group, with no allocation to different treatments and no masking.
Primary question
The planned primary outcome was rating scores for skin erythema, pallor, maceration, and denudation at Day 15. The registry record does not report the scores or a statistical analysis of them, so it does not establish how those ratings changed during the study.
The clinical question is therefore descriptive: what skin-rating observations were planned during use of HP828-101 in adults with moisture associated skin damage? The design does not support a like-for-like comparison with another treatment or with an untreated group. Without a comparator, changes over time could not be separated from other influences using a between-group contrast. The record lists secondary assessments of skin ratings at Day 4, 8, and 12, the proportion of subjects with no denuded skin area at Day 4, 8, 12, and 15, and pre- and post-treatment surveys. The registry does not report numerical findings for these outcomes either. The study status is terminated; the record does not say why it was terminated or whether the planned follow-up was completed for every participant.
3. Trial Design
This was an open-label, single-group study of HP828-101, identified as an experimental formulation and classified as a device. The official title describes an evaluation in adults with moisture associated skin damage. The phase is listed as EARLY PHASE1. Allocation is listed as not applicable, and masking is listed as none. These features mean the record describes neither random assignment to study groups nor blinded assessment.
The registry lists enrollment of 7. The study started in 2010-04, and primary completion is recorded as 2010-07. Its current status is terminated. The registry record does not explain the termination, state whether enrollment reached its planned target, or describe the circumstances of study completion. The sponsor is Healthpoint.
The primary outcome was rating scores for skin erythema, skin pallor, skin maceration, and skin denudation at Day 15, with a timeframe of 15 Days. No measurement unit, parameter, dispersion measure, or outcome population is specified in the record. Secondary outcomes include ratings of the same skin features at Day 4, 8, and 12; the proportion of subjects with no denuded skin area at Day 4, 8, 12, and 15; and pre- and post-treatment surveys.
Because there is only one group, the design can describe observations made during treatment but does not provide a randomized treatment contrast. The registry does not report a protocol-level statistical analysis plan, a sample-size justification, or whether outcome assessment followed a prespecified schedule for all participants. It also does not report participant disposition or the analysis population. Those omissions limit interpretation of both the planned design and the completeness of any outcome evidence.
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 | HP828-101 |
|---|---|
| STARTED | 7 |
| COMPLETED | 3 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | HP828-101 |
|---|---|
| Protocol Violation | 4 |
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 | HP828-101 |
|---|---|---|
| Participants analysed | 7 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 6 |
| Age Continuous | years | 74.9 (SD 15.6) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 4 |
| Region of Enrollment: United States | participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15., measured over 15 Days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is described as rating scores for skin erythema, pallor, maceration, and denudation at Day 15. These are clinical features of the skin that the study planned to assess while evaluating HP828-101 for moisture associated skin damage. The listed timeframe is 15 Days.
In general, a prespecified primary endpoint identifies the main outcome used to address a study's central question. Naming the measure and its timing helps readers understand what was intended to be assessed and when. Skin ratings may also offer a structured way to describe features of the affected area, but the registry does not state the rating scale, how scores are combined or interpreted, or what change would be considered meaningful. It does not provide a measurement unit or statistical parameter.
The registry record gives no numerical Day 15 ratings, summary statistics, or analysis results for this endpoint. It therefore documents what was planned, not an observed result that can be interpreted as evidence of improvement or worsening. Ratings at earlier visits appear among the secondary outcomes, but their numerical results are also not reported in the registry record. Without the scale details and results, readers cannot assess the magnitude, variability, or precision of any change in the listed skin features.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, open-label, single-group evaluation, with enrollment of 7 and no separate comparator. Its primary outcome was planned as ratings of erythema, pallor, maceration, and denudation at Day 15. However, the registry does not report numerical values for those ratings, a summary of change, or an inferential analysis. It lists 0 analyses. The posted registry information therefore does not allow readers to determine the direction or size of any primary outcome change, or how precise an estimate might be.
The absence of a comparator matters independently of the missing outcome values. In general, an observed change within a single group does not isolate the effect of an intervention from other possible influences, such as natural variation over time or changes in care. This is not a randomized comparison, so a treatment contrast cannot be derived from the design. No causal conclusion about HP828-101 can be drawn from the record's design description alone.
The registry lists secondary outcomes that could have described skin ratings at Day 4, 8, and 12, the proportion with no denuded skin area at Day 4, 8, 12, and 15, and pre- and post-treatment surveys. Numerical findings for these outcomes are not reported in the registry record. Consequently, those planned measurements do not supply additional evidence about outcome trajectories or participant-reported experience in the available record.
Precision also cannot be assessed from the information recorded. Confidence intervals, standard errors, and variability estimates for the primary outcome are not reported. In general, a confidence interval communicates the range of values compatible with the data under the chosen statistical model; without an estimate and interval, neither the magnitude nor its uncertainty can be evaluated. The record also does not explain whether rating scores were treated as ordinal or continuous measurements, or how missing observations were handled.
Safety information is limited to the adverse-event figures in the registry: one serious adverse event is listed among 7 at risk, and the top serious term is metastatic brain cancer at 14.3%. No non-serious adverse events are listed among 7 at risk. The record does not establish whether the serious event was related to HP828-101, and these figures alone do not establish causation. Overall, the record documents a planned early-phase evaluation but does not provide enough outcome analysis to estimate efficacy, precision, or comparative safety.
9. Statistical Methods Explained
The registry describes a single-group study with no allocation to different treatment groups and no masking. This is a descriptive design rather than a randomized comparison. In general, random allocation helps balance known and unknown factors across groups, while a concurrent comparator gives a reference for interpreting observed outcomes. Neither feature is present in this record. An open-label design also means masking is not used; the registry does not explain who assessed the skin ratings or whether any standardized safeguards were used to limit assessment bias.
What does a single-group result represent?
In general, a single-group study can report the outcomes observed among participants who received the intervention. If repeated assessments are available, they can describe how observations vary across visits. Such within-group descriptions are not equivalent to an estimate of the intervention's effect relative to an alternative. Changes may reflect influences other than the intervention, and a single group does not provide a concurrent estimate of what would have happened without it. For this study, the registry identifies planned visits and ratings but does not provide the numerical observations needed to describe change.
What would the ratings need to show?
The primary endpoint names four skin features and a Day 15 assessment. The registry does not describe the rating scale, its possible score values, the direction of better or worse scores, or whether the four features are analyzed separately or combined. In general, these details matter because the measurement scale determines how scores can be summarized and which statistical methods are appropriate. For example, ordinal ratings represent ordered categories, while continuous measurements can support different summaries and models. The record does not state which measurement properties apply to these ratings. It also does not report a prespecified primary contrast or a statistical test.
What does the absence of analysis entries mean?
The registry lists 0 analyses and does not report numerical primary or secondary outcome results. This means there is no reported estimate, standard error, confidence interval, or test result available for interpretation. In general, an estimate describes the observed quantity, while a confidence interval expresses uncertainty around it under a specified model. A p-value, when reported, addresses compatibility with a null hypothesis under the analysis assumptions; it does not by itself describe the size or clinical importance of an effect. None of these inferential quantities for the skin-rating outcomes is reported in the registry record.
The record does not state whether the primary endpoint was analyzed as a change from baseline, as a Day 15 value, or in another way. Baseline measurements are not described in the primary outcome entry. The analysis population, handling of repeated measurements, model specification, and missing-data approach are also not reported in the registry record. These details are necessary to understand which observations contribute to an estimate and what assumptions support it.
Why do model assumptions matter?
General statistical models make assumptions about how observations vary and how their distributions relate to the quantities being estimated. If observations are more variable than a model allows, standard errors may be too small and confidence intervals may be too narrow; this is one reason over-dispersion matters in analyses of count or proportion data. The registry does not identify a model for the skin scores or the secondary proportion outcome, so it is not possible to assess whether any particular distributional assumption was used or appropriate. No model-based results are reported.
The study's enrollment is listed as 7, but the registry does not provide a sample-size justification or explain what precision or effect the study was intended to detect. In general, sample-size planning depends on the outcome, variability, chosen analysis, and design. A planning illustration based on an observed effect would not be an observed result and would not establish that a study had adequate power. No calculated planning values are stated in the registry record, and no such values can substitute for missing outcome estimates or a prespecified design rationale.
Finally, safety counts are descriptive summaries, not a causal analysis. The record lists a serious adverse event and a serious-event term, but does not report an attribution assessment, comparison group, or statistical analysis of safety. In general, counts should be interpreted in light of the number followed, the observation period, event definitions, and completeness of reporting. The registry does not provide all of those details. The most defensible statistical reading is therefore limited to the study design and the events explicitly listed, without extrapolating to comparative risks or causation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome description and several secondary outcome categories, including repeated ratings at Day 4, 8, and 12, the proportion without a denuded skin area at Day 4, 8, 12, and 15, and pre- and post-treatment surveys. It does not report a multiplicity strategy, such as a hierarchy among outcomes or an adjustment for testing multiple measures. It also does not report statistical tests or numerical results for these outcomes. Without an analysis plan and results, it is not possible to evaluate how multiple outcome questions were handled.
Missing-data methods are not reported in the registry record. The record does not state how many participants had each assessment, whether participants missed visits, or whether any outcome data were excluded. It does not describe imputation, complete-case analysis, or other approaches to incomplete observations. Those omissions prevent assessment of whether the reported population, if any, would represent all enrolled participants or whether missingness could affect interpretation.
The analysis population is also not reported in the registry record. There is no description of whether analyses were intended to include all enrolled participants, only those who completed treatment, or another defined group. In general, the population used in an analysis affects the interpretation of its estimate, particularly when participants discontinue or do not provide all planned measurements. The study status is terminated, but the reason for termination and participant disposition are not reported. No assumptions about the handling of multiplicity, missing observations, or analysis populations can therefore be inferred from the registry entry.
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 |
|---|---|---|---|
| HP828-101 | 1 | 7 | 14.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HP828-101 | 0 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | HP828-101 |
|---|---|---|
| Metastatic brain cancer | Nervous system disorders | 1 of 7 |
Serious events with the highest arm-level rate: metastatic brain cancer (14.3%).
The registry lists one serious adverse event among 7 at risk in the HP828-101 group. The top serious-event term is metastatic brain cancer, listed at 14.3%. It lists no non-serious adverse events among 7 at risk. The deaths entry is not reported.
These are descriptive registry figures. The record does not state whether the serious event was judged related to HP828-101, when it occurred, or whether it led to treatment discontinuation. The term and percentage should not be read as evidence that the intervention caused the event. A single-group study also provides no concurrent group against which to compare event frequency.
In general, safety counts depend on how events are defined, collected, and attributed, as well as the observation period and completeness of follow-up. The registry record does not provide a detailed safety-analysis plan or additional context for these figures. The listed serious event should therefore be read as an event recorded in the study, not as a comparative risk estimate. The absence of listed non-serious events does not establish that no other events occurred outside the information recorded in the registry.
12. What the Result Does, and Does Not, Mean
The record establishes that an open-label, single-group study of HP828-101 was registered for adults with moisture associated skin damage, with enrollment of 7 and a planned primary assessment of skin erythema, pallor, maceration, and denudation at Day 15. It also records secondary skin-rating assessments, a measure concerning absence of denuded skin area, and pre- and post-treatment surveys. These details describe the intended clinical question and outcome schedule.
The record does not report numerical outcome results or analysis entries. It therefore does not establish whether skin ratings changed, the size or consistency of any change, or the uncertainty around an estimate. Nor does it allow an assessment of the listed secondary outcomes. The absence of results in the registry entry is not evidence that an outcome did or did not occur; it means the relevant result is not reported in the registry record.
The single-group design cannot provide a randomized comparison with another treatment or a control group. In general, observations made during treatment cannot on their own separate an intervention effect from other causes of change over time. The open-label design also does not use masking, and the record does not specify how outcome assessment was conducted. These limits apply even if numerical within-group results were available.
The safety entry records one serious adverse event, with metastatic brain cancer listed as the top serious term, and no non-serious adverse events. The registry does not report attribution, so the serious event cannot be assigned to HP828-101 from these data. The study's terminated status is recorded, but its reason is not reported in the registry record.
In short, the registry entry documents a study plan and limited safety counts, not an interpretable estimate of treatment effect. It does not establish efficacy, lack of efficacy, comparative safety, or causation.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it illustrates the difference between a registered clinical question and an answer supported by reported results. The record specifies an intervention, a single study group, a primary assessment time, and several planned secondary outcomes. Those details help define what investigators intended to examine. But without numerical outcome findings and analysis results, the central statistical quantities—an estimated change, its variability, and its precision—are unavailable.
The design also makes the limits of within-group evidence visible. A single group can be followed over time, but a change in observed ratings does not by itself show what would have happened under another treatment or without the intervention. The lack of allocation and masking further distinguishes this study from a blinded randomized comparison. These are design constraints, not defects that can be repaired by statistical analysis after the fact.
The record highlights the importance of endpoint specification. It names four skin features and a Day 15 timeframe, yet does not describe the rating scale, score interpretation, or analysis method. In general, a clearly defined outcome and analysis plan are needed to interpret both the estimate and its uncertainty. Naming an outcome alone is not enough to determine what a result would mean.
Finally, the safety listing shows why event counts require context. A serious event is recorded, but the registry does not state attribution or provide a comparator. The figures are important to read as recorded events, not as a causal or comparative conclusion. Overall, the study matters statistically as an example of how design, outcome definition, completeness of reporting, and analysis jointly shape what can be concluded from a trial record.
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.
Several limitations are specific to this registry record. It describes an open-label, single-group study with allocation listed as not applicable and no masking. There is no separate control group, so the design does not support a like-for-like treatment comparison. The record gives an enrollment of 7, but does not describe the recruited participants in enough detail to assess how representative they may be of adults with moisture associated skin damage.
The primary endpoint is named, but its measurement scale and scoring rules are not described. The record does not explain whether the four skin features are assessed separately, how ratings are interpreted, or what degree of change would be meaningful. It also does not report a baseline value, numerical Day 15 results, or analysis results. The secondary outcomes are listed without numerical findings.
Study status is terminated, but the reason is not reported in the registry record. Participant disposition, the number with follow-up assessments, protocol deviations, and analysis populations are not described. The record does not report a sample-size justification, statistical analysis plan, missing-data approach, or method for handling multiple outcomes. These gaps prevent assessment of the analysis assumptions and completeness of outcome reporting.
The safety information is also limited. A serious event is listed, but attribution and detailed timing are not reported. With no comparator and no contextual safety analysis, the registry figures cannot establish a causal relationship or a comparative event rate. Together, the design and reporting limitations mean the entry is best read as a description of a planned evaluation and limited recorded safety information, rather than as a complete account of treatment outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage — NCT01108523.
- Registry record last updated 2013-12-06; status last verified 2013-10.
- Results first posted 2013-12-06.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01108523 is an open-label, single-group evaluation of HP828-101 for moisture associated skin damage in adults. The intervention is identified as an experimental formulation and classified as a device. The registry lists the phase as EARLY PHASE1, enrollment of 7, a start in 2010-04, primary completion in 2010-07, and status as terminated. Healthpoint is listed as sponsor.
The primary outcome was skin-rating scores for erythema, pallor, maceration, and denudation at Day 15. Secondary outcomes included earlier ratings, absence of denuded skin area, and pre- and post-treatment surveys. Numerical outcome results and analysis entries are not reported in the registry record. Safety listings include one serious adverse event among 7 at risk, with metastatic brain cancer at 14.3% as the top serious term, and no non-serious adverse events listed.