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 Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck (NCT03803059), a na na study. The primary outcome is Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03803059 |
| Phase | NA |
| Condition | Wrinkles |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bellus Medical, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Men and women with wrinkles of the neck were included. The registry record lists the condition as wrinkles and an enrollment of 35. The primary analysis population is described as participants who completed the study; the number completing it is not reported in the registry record.
Intervention
The intervention was SkinPen Precision, a device used for microneedle treatment of neck areas. The record describes assessment over the treatment period and subsequent post-treatment visits. Details about the number of treatments, treatment settings, or other procedural particulars are not reported in the registry record.
Comparator
This was a single-group study, not a randomized comparison. The registry record does not describe a separate control group or an alternative treatment group. Consequently, the study does not provide a like-for-like comparison of SkinPen Precision with another intervention or with no treatment.
Primary question
The primary question concerned neck-wrinkle severity assessed with the Lemperle Wrinkle Assessment Scale at Day 1 and 3 Month Post Treatment. The scale assigns categories from no wrinkles through very deep wrinkles with a redundant fold. Although the registry identifies mean and standard deviation as the summary measures, the primary outcome results are not reported in the registry record.
In practical statistical terms, this is a question about observed wrinkle-score measurements over time in a treated group. The registry record identifies the population, device, assessment scale, and stated assessment times, but it does not provide the underlying scores or a numerical estimate of change. It therefore does not establish the magnitude or precision of any change in the recorded score. The design also cannot separate a treatment-associated change from changes that might occur over time for other reasons. Those distinctions matter when interpreting a before-and-after assessment without a concurrent comparison group.
3. Trial Design
The registry describes a single-center trial of SkinPen Precision for neck wrinkles in male and female participants. It lists 35 enrolled participants and a completed status. The record gives a start date of 2019-01-31 and a primary completion date of 2020-01-10. The phase is listed as NA, and allocation is listed as NA. Masking is listed as none. The study model is single group, so the design does not include a randomized control comparison.
The intervention is identified as a device, with the treatment described as microneedle treatment of neck areas. The study summary says the clinical trial was conducted over 90 days, followed by 1-month and 6-month post-treatment visits. The primary outcome specifies wrinkle assessment at Day 1 and 3 Month Post Treatment. How those visit descriptions correspond to the protocol schedule is not further detailed in the registry record. The number of participants who attended each assessment is not reported in the registry record.
The registry identifies a completed-participant analysis population for the primary endpoint. It does not state how many participants completed the study or how incomplete observations were handled. The record lists 12 outcome measures and 12 analyses, with secondary measures that include aesthetic ratings, skin barrier and structural measures, and mechanical measurements. The specific analysis methods for these outcomes are not reported in the registry record.
A single-group design can describe measurements recorded in participants receiving the intervention, but it does not supply an untreated or alternative-treatment trajectory for comparison. Changes over time may reflect several influences, and a design without a concurrent control cannot distinguish those influences using a between-group contrast. The registry record does not report a protocol rationale for the design, a sample-size justification, or details of any interim analyses.
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.
Before assignment: Only participants who met eligibility requirements were enrolled into the study. The subjects were given Pre-study instructions that include wash out Period: No topical medications or topical retinoids 2 weeks prior to visit 1.
Overall Study
| Stage | Skinpen Precision System |
|---|---|
| STARTED | 35 |
| COMPLETED | 32 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Skinpen Precision System |
|---|---|
| Protocol Violation | 2 |
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis population includes all participants completing the study.
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.
Population: At visit 1 (baseline), subjects were screened for eligibility criteria and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2. 35 Subjects were analyzed using the Fitzpatrick wrinkle scale and their scores are recorded.
| Characteristic | Unit | SkinPen Precision System |
|---|---|---|
| Participants analysed | 35 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 35 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 33 |
| Sex: Female, Male: Male | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 31 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Fitzpatrick Skin Classification: l | participants | 0 |
| Fitzpatrick Skin Classification: ll | participants | 25 |
| Fitzpatrick Skin Classification: lll | participants | 5 |
| Fitzpatrick Skin Classification: lV | participants | 5 |
| Fitzpatrick Skin Classification: V | participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale, measured over Day 1 and 3 Month Post Treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Score on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is wrinkle severity in the neck region assessed using the Lemperle Wrinkle Assessment Scale. The registry describes categories running from Class 0, no wrinkles, to Class 5, a very deep wrinkle with a redundant fold. Intermediate descriptions range from a just perceptible wrinkle to deep wrinkles with well-defined edges. A structured scale gives assessors a common framework for describing severity and can make observations easier to summarize consistently than an unstructured narrative description.
The stated assessment times are Day 1 and 3 Month Post Treatment. The registry identifies the endpoint as a mean, with standard deviation as its dispersion measure, and gives the unit as a score on a scale. A mean can describe the central score across participants, while a standard deviation describes how spread out individual scores are around that mean. Those summaries do not, on their own, show the score distribution or how individual participants changed.
The scale uses ordered categories. In general, category order conveys that one level represents greater severity than another, but the distance between adjacent categories is not necessarily equal. A mean can be a compact summary of ordered scores, but its interpretation depends on that scoring convention. The registry does not report the actual scores, a change estimate, or uncertainty around the primary outcome. It also does not report details about assessor training or consistency.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the primary endpoint and its assessment times, but it does not report primary outcome values. In particular, it provides no mean score at either stated assessment, no estimated change, no standard deviation for the observed scores, and no confidence interval or test result for the primary endpoint. The direction, size, and precision of any observed change therefore cannot be evaluated from the registry information recorded in this trial summary.
The distinction between an endpoint description and a result is important. Naming a scale, a unit, and a statistical summary tells readers what investigators intended to measure and how they intended to describe it. It does not reveal what participants scored or whether the scores changed. Likewise, a completed study status and an enrollment figure do not substitute for outcome data. The number of participants in the primary analysis is not reported in the registry record.
Even if before-and-after scores were available, their interpretation would be limited by the single-group design. A change between Day 1 and a later visit would describe a within-group pattern, but without a concurrent comparator it would not isolate the effect attributable to the device. Time trends, measurement variation, expectations, and other influences could also contribute. This is a general limitation of interpreting change in an uncontrolled study, not a claim about what occurred in this trial.
The registry lists several secondary measures, spanning subject ratings and instrument-based assessments. It does not report their numerical results in the record. Nor does it explain whether a primary result was selected from multiple analyses, whether any planned analysis was changed, or how results across outcomes should be interpreted together. No inference about statistical significance or practical importance can be made without the estimates and their uncertainty.
The safety record lists no serious adverse events among 35 at risk and 10 other adverse events among 35 at risk. These counts describe the recorded safety categories; they do not establish whether an event was caused by the device. The record does not list serious-event terms. These safety counts do not fill the gap in primary efficacy results. Overall, the registry description supports understanding what the trial set out to measure and its broad design, but not estimating the primary outcome effect or its precision.
9. Statistical Methods Explained
The registry identifies the primary measure as continuous for analysis, summarized by a mean and standard deviation. The underlying scale is ordered by wrinkle severity. These registry entries describe the planned form of the summary, not the observed outcome: the numerical scores and their summaries are not reported in the registry record.
What does a mean describe?
In general, a mean is the arithmetic average of measured scores and provides a single description of their center. A standard deviation describes how much individual scores vary around that center. A mean and standard deviation are most informative when readers can also understand the score range, the pattern of observations, and the number of participants contributing data. The range and distribution of actual scores are not reported in the registry record.
For a scale made up of ordered categories, the ranking of categories is clear, but equal spacing between categories is not guaranteed. For example, the difference in severity represented by two neighboring categories need not be identical to the difference represented by another neighboring pair. In general, treating ordered scores as numerical values can be convenient for summarization, but interpretation should recognize that assumption. The registry does not report a rationale for choosing a mean-based summary or a sensitivity analysis using another approach.
What would an estimate and confidence interval add?
In general, an estimate describes the size and direction of an observed quantity, while a confidence interval communicates uncertainty around that estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but an interval is not a guarantee that the true value lies within it. For this trial, the primary estimate and its confidence interval are not reported in the registry record, so neither the magnitude nor precision of the primary outcome can be assessed.
The stated time points make the endpoint longitudinal in the broad sense that measurements are intended at more than one visit. A within-participant comparison would need to account for the relationship between observations from the same person. In general, observations from one participant tend to be more alike than observations from different participants, so treating repeated measurements as independent can misstate uncertainty. The registry record does not describe whether a paired method, repeated-measures model, or another approach was used.
Why does the single-group structure matter?
A single-group study can describe scores over time among participants who receive the intervention. It does not estimate a randomized contrast against a concurrent control group. Without that comparison, a change in score cannot be attributed uniquely to treatment. This limitation is about what the design can identify; it does not imply that a change did or did not occur. The registry lists allocation as NA and the study model as single group.
For a randomized comparison, an analysis may estimate a difference between treatment groups, with uncertainty reflecting the observed data and analysis assumptions. That kind of contrast is not available in this study design. A within-group before-and-after change, if reported, would answer a different question and should not be described as a treatment-versus-control effect.
What does over-dispersion mean in general?
Over-dispersion occurs when observed variability is greater than a statistical model expects. If it is ignored, standard errors and confidence intervals can be too small, making results appear more precise than the data support. It is relevant to certain models for counts or categorical outcomes, depending on their assumptions. The primary endpoint is described through a mean and standard deviation, and the registry does not report a model assessment or an over-dispersion analysis. No claim can be made that over-dispersion was present or addressed.
More generally, model choice should match the measurement scale and study design. For ordered categories, an ordinal model may preserve the ordering without assuming equal spacing. A mean-based summary offers a different, compact description. Neither can be identified as the method used beyond the registry's statement that the primary measure is a mean with standard deviation. The details of any fitted model, covariate adjustment, diagnostic checks, or alternative analyses are not reported in the registry record.
How should planning calculations be read?
In general, sample-size calculations are planning exercises based on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. They do not measure the probability that a completed trial's result is correct. A planning illustration based on an observed effect is not observed power and is not evidence that the trial was adequately powered. The registry record does not report its own sample-size justification. Any specific planning values or assumptions beyond those described in the record are not reported in the registry record.
Recalculated estimates, when available, are unadjusted calculations from posted summary statistics and are not a replacement for the sponsor's own analysis. No primary summary statistics for this endpoint are reported in the registry record, so a recalculated primary effect cannot be interpreted from these registry entries. In general, the sponsor's own analysis takes precedence if a recalculation conflicts with it; the record does not provide a sponsor analysis result for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures and 12 analyses, including a primary wrinkle-severity measure and secondary measures covering aesthetic ratings and several skin or tissue measurements. When multiple outcomes or analyses are examined, the chance of at least one apparently notable result can increase. In general, adjustment procedures or a clearly prespecified hierarchy can help readers understand how multiplicity was handled. The registry record does not report whether any multiplicity adjustment, outcome hierarchy, or other strategy was used.
The primary outcome population is described as all participants completing the study. The number who completed the study, and the number with primary endpoint data at each time, are not reported in the registry record. The record does not describe how missing observations were handled, whether participants were excluded from analysis, or whether imputation or a sensitivity analysis was used. These details matter because an analysis limited to completers can differ from one that includes all enrolled participants, particularly if missingness is related to outcomes or participant characteristics.
In general, missing-data methods rely on assumptions about why observations are absent. Complete-case analysis uses available observations but can be biased if the observed participants differ systematically from those without measurements. Imputation and likelihood-based methods also require assumptions and should be described alongside sensitivity analyses when appropriate. None of these methods can be attributed to this study from the registry record.
Also not reported in the registry record are a detailed statistical analysis plan, prespecified decision rules, interim analyses, or a sample-size justification. Their absence from the record means readers cannot verify from this information how analysis choices were specified or whether they changed.
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 |
|---|---|---|---|
| Skinpen Precision System | 0 | 35 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Skinpen Precision System | 0 of 35 |
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 |
|---|---|
| Skinpen Precision System | 10 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Skinpen Precision System |
|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 35 |
| Fall | Musculoskeletal and connective tissue disorders | 1 of 35 |
| Dermatitis | Skin and subcutaneous tissue disorders | 1 of 35 |
| Kidney infection | Infections and infestations | 1 of 35 |
| Kidney Stone removal | Renal and urinary disorders | 1 of 35 |
| Root canal | Gastrointestinal disorders | 1 of 35 |
| Meniscus repair | Gastrointestinal disorders | 1 of 35 |
| Sleep Apnea | Nervous system disorders | 1 of 35 |
| Biopsy on Jawline | Surgical and medical procedures | 1 of 35 |
| Viral Bronchitis | Infections and infestations | 1 of 35 |
The registry safety figures list 35 participants at risk for serious adverse events, with 0 serious adverse events recorded. For other adverse events, it lists 35 participants at risk and 10 affected. These are counts in the registry's safety categories. They should not be converted into claims about event rates or compared with another treatment without appropriate data and a suitable comparison.
A serious adverse event is a safety category distinct from other adverse events. The record lists no serious-event terms, so it does not identify particular serious events for this study. The category of other adverse events is not further described in the information recorded. The figures do not state the severity, timing, duration, or outcome of the other events, nor do they establish whether any event was related to the device.
In general, safety counts depend on how events were defined, collected, and classified, and on the period of observation. A zero count in a study does not prove that an event is impossible or that no risk exists. These counts describe the record for this study and its listed participants at risk; they are not a comparative safety estimate. Further details about event definitions, attribution, and follow-up are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
This trial record establishes that a single-center, single-group study evaluated SkinPen Precision for neck wrinkles in men and women. It identifies the Lemperle Wrinkle Assessment Scale as the primary measure and gives the stated assessment times. It also records safety counts and lists a range of secondary measures. Those details help define the clinical question and the type of evidence the study was designed to collect.
The registry record does not report primary outcome results. It therefore does not support a conclusion about whether the measured wrinkle scores changed, how large any change was, or how precisely it was estimated. The absence of a reported result is not evidence that there was no change. It also does not establish that any change occurred. The actual primary scores, analysis population size, and uncertainty estimates are not reported in the registry record.
The design places another limit on interpretation. Because the study has a single group and no randomized comparator, it cannot provide a controlled estimate of the difference between SkinPen Precision and another intervention or no treatment. If a before-and-after change were available, it would describe the observed course in the treated group; other influences could also explain some or all of that pattern. This is a general design limitation, not a statement about the trial's unreported outcome.
The safety counts should likewise be read narrowly. They report the recorded number of participants in the serious and other adverse-event categories, but do not establish causation or comparative safety. The record's completed status indicates study status, not that the intervention achieved a particular outcome. Overall, the registry information is useful for describing study structure and intended measurement, but it is insufficient for judging the size, precision, or causal meaning of a primary treatment effect.
13. Why This Trial Matters Statistically
Statistically, the trial illustrates why design, measurement, and reporting need to be read together. The registry names a specific wrinkle scale and identifies summary measures and assessment times. That gives readers a framework for understanding what investigators intended to quantify. Yet without the observed scores and an estimate of change, the central statistical question remains unanswered in the registry record.
The single-group structure is also consequential. Within-group follow-up can describe what happened to measured scores over time among participants in the study. It cannot by itself distinguish treatment-associated change from time effects, measurement variation, or other influences. A randomized concurrent comparison would address a different question by estimating a contrast between groups; this record does not describe such a comparison.
The scale itself raises a useful measurement issue. Its categories are ordered by severity, while equal distances between categories are not established by the descriptions. A mean and standard deviation offer a familiar summary, but readers should consider what those summaries imply about an ordered score. Distributional details, participant-level changes, and alternative analyses would help contextualize a mean-based account; these are not reported in the registry record.
Finally, the record lists multiple outcomes and analyses but does not report how multiplicity or missing data was handled. Such details affect how confidently readers can interpret a collection of results. The trial matters statistically as an example of the distinction between a clearly identified measurement plan and a fully interpretable result: both the design and complete reporting are needed to assess magnitude, uncertainty, and causal interpretation.
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 principal limitation in the registry record is that primary outcome values are not reported. Without the scores at the stated assessment times, an estimated change, and a measure of uncertainty, readers cannot evaluate the size or precision of the primary result. The number of participants contributing primary data is also not reported, despite the stated analysis population of participants completing the study.
The study is single group and has no randomized comparator. This limits causal interpretation because observed change over time cannot be separated from other possible influences using a concurrent control contrast. The record does not describe a control condition, random allocation, or masking; masking is listed as none. These features should be considered when judging what conclusions the design could support.
The primary measure is an ordered wrinkle-severity scale summarized as a mean and standard deviation. The registry does not explain the rationale for this summary or report score distributions, assessor reliability, or sensitivity analyses. It also does not provide detail about treatment procedures beyond microneedle treatment of neck areas, such as treatment settings or number of sessions.
Additional reporting gaps include the handling of missing observations, multiplicity across the listed outcomes, analysis methods, and any sample-size justification. The number of participants who completed follow-up and the relationship between the different visit descriptions are not reported in the registry record. These limitations concern what can be learned from the available registry information; they do not establish that an unreported method was or was not used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck — NCT03803059.
- Registry record last updated 2021-12-01; status last verified 2021-07.
- Results first posted 2021-12-01.
- 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
The registry record describes a completed, single-center, single-group device study of SkinPen Precision for neck wrinkles in men and women. It lists enrollment of 35, no masking, and allocation as NA. The primary endpoint is the Lemperle Wrinkle Assessment Scale, summarized as a mean and standard deviation, with assessments at Day 1 and 3 Month Post Treatment. The study summary also describes a 90-day period followed by 1-month and 6-month post-treatment visits.
The record lists 12 outcome measures and 12 analyses. It reports 0 serious adverse events among 35 at risk and 10 other adverse events among 35 at risk. Primary outcome values, analysis details, missing-data handling, and the number completing the study are not reported in the registry record. The single-group design does not provide a randomized comparison.