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 Botox Cosmetic and the Young Patient With Glabellar Furrows (NCT00856999), a na phase 4 study. The primary outcome is Reduction of the Facial Wrinkle Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00856999 |
| Phase | Phase 4 |
| Condition | Glabellar Furrows |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oregon Health and Science University |
| Results posted | Yes |
2. Clinical Question
Population
The registry record identifies glabellar furrows as the condition and describes the study as concerning a young patient population. Specific age criteria and other eligibility details are not reported in the registry record. Enrollment was 50; the record does not establish how many participants contributed data to the primary outcome.
Intervention
Participants received Botox Cosmetic. The recorded administration description specifies 4 units per injection site over 5 sites, treating the procerus and corrugator superciliaris muscle groups. The study summary describes a different dosing schedule intended to assess whether effects lasted longer than with a standard injection regimen. The precise schedule and timing of individual injections are not reported in the registry record.
Comparator
There was no listed control group for a like-for-like comparison. The study is recorded as single-group, with allocation marked NA and masking marked none. It therefore does not provide a randomized comparison between the described regimen and a separate standard-regimen group.
Primary question
The primary outcome was reduction of the Facial Wrinkle Scale (FWS), measured in units on a scale, with a primary timeframe of 26 months. The record describes baseline to 20 months as the active injection phase and 20 months to 26 months as follow-up. It does not report the numerical FWS results or a numerical estimate of change. The record therefore describes the question and assessment period, but does not establish the size or precision of the observed outcome.
3. Trial Design
This was a completed Phase 4 study sponsored by Oregon Health and Science University. Its registry record gives an enrollment of 50 and identifies a single-group model. Allocation is listed as NA, and masking as none. These design features describe a study without a randomized, masked comparison group; they do not support a direct between-group estimate of the effect of one regimen relative to another.
The intervention was Botox Cosmetic. The arm description records 4 units per injection site over 5 sites, directed at the procerus and corrugator superciliaris muscle groups. The brief summary says the study used a different dosing schedule to examine whether effects lasted longer than those of the standard injection regimen. The detailed timing, frequency, and full sequence of administrations are not reported in the registry record, so the intended schedule cannot be reconstructed from these entries alone.
The study began on 2005-02-08, and its primary completion date was 2010-11-17. Its status is completed. The primary measure was reduction of the FWS, with a timeframe of 26 months. The description separates baseline to 20 months as the active injection phase and 20 months to 26 months as follow-up. The record lists 2 outcome measures and 2 analyses, but does not identify the analysis methods or report numerical primary-outcome results.
The enrollment figure is not necessarily the number included in an outcome analysis. The number assessed at each time point, the number with missing measurements, and the analysis population are not reported in the registry record. Without those details or numerical outcome summaries, the design and assessment plan can be described, but the magnitude and precision of any change cannot be evaluated.
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 | Botox |
|---|---|
| STARTED | 50 |
| COMPLETED | 45 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Botox |
|---|---|
| Withdrawal by Subject | 5 |
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 | Botox |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 50 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 50 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 50 |
| Facial wrinkle scale | units on a scale | 2.78 (0 to 3) |
6. Primary Endpoint
The registry lists the primary outcome as Reduction of the Facial Wrinkle Scale, measured over 26 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled “Reduction of the Facial Wrinkle Scale.” The FWS is described as a validated four-point scale, with a minimum score of 0 for no wrinkles and a maximum score of 3 for deep wrinkles. The outcome is recorded in units on a scale, with the mean as the stated parameter and the standard deviation as the stated measure of dispersion. These descriptors indicate that the intended result is a continuous summary of wrinkle-scale scores rather than a count of events.
A wrinkle scale offers a structured way to record facial appearance at assessments. Using the same defined scale over time can support description of change within a study group. In general, a mean conveys the average score in the analyzed group, while a standard deviation describes how spread out individual scores are around that average. Neither statistic alone shows the range of individual experiences or the uncertainty around an estimated change.
The recorded timeframe is 26 months. The description identifies baseline to 20 months as the active injection phase and 20 months to 26 months as follow-up. Although the endpoint title refers to reduction, the precise calculation of the primary result—such as which time points were contrasted or how repeated measurements were handled—is not reported in the registry record. Numerical means, standard deviations, and a numerical estimate of change are also not reported in the registry record. The purpose of the scale and timing can therefore be described, but the observed endpoint result cannot be quantified from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question, intervention description, endpoint, and follow-up timeframe, but does not provide the numerical result for the primary outcome. It is therefore not possible to state the average FWS score, the amount of reduction, the variability of scores, or the precision of an estimated change. The endpoint title alone is not evidence that a reduction occurred or that any change had a particular size.
The design is single-group, with allocation marked NA and masking marked none. There is no recorded randomized control group against which to compare the treatment schedule. Any change observed within a group could be described over time, but a within-group change is not the same as a randomized estimate of what would have happened under another regimen. In general, a comparison group can help separate changes associated with an intervention from changes that might occur over time or through other influences. That type of contrast is not available in the recorded design.
The brief summary frames the study around whether consistent treatment might lead to longer-lasting effects than the standard injection regimen. The registry entries a baseline-to-20-month active phase and a 20-to-26-month follow-up phase. However, the timing and frequency of injections, the observed FWS values at assessment points, and the statistical contrast used to assess durability are not reported in the registry record. The intended question should not be mistaken for a reported finding.
The record lists the mean and standard deviation as the endpoint summary and dispersion measure. In general, a mean describes a group average, whereas a standard deviation describes variation among observations. To judge statistical precision, readers would also need an uncertainty measure, such as a confidence interval, or another reported inferential result. Those numerical details are not reported in the registry record. The number enrolled does not substitute for those results and does not indicate how many participants had complete outcome data.
Accordingly, the posted information supports a description of the study structure and planned outcome, not a conclusion about the size, consistency, or precision of an observed effect. No treatment benefit or lack of benefit can be inferred from the absence of a numerical primary result. The safety entries should likewise be read as reported event counts, rather than as a complete characterization of safety over time.
9. Statistical Methods Explained
The endpoint is continuous: it is a score summarized using a mean, with a standard deviation as the stated dispersion measure. General explanation: a mean condenses a set of observations into an average, and a standard deviation describes how widely individual observations vary around that average. These answer different questions. A group average does not show whether most observations were close to that value or whether scores varied substantially.
What does the scale represent?
The FWS is described as a validated four-point scale ranging from 0, meaning no wrinkles, to 3, meaning deep wrinkles. The record expresses the endpoint in units on a scale. A score scale can make observations more consistent by giving assessors defined categories, but the registry record does not specify assessor training, assessment procedures, or whether assessors were blinded. Masking is recorded as none, so no masking procedure is described for the study.
What can a mean change show?
In general, a change in a group mean can summarize how the average score differs between defined assessments. To interpret such a result, readers need to know the assessments being compared, the direction of subtraction or change, and the population included in the calculation. The registry description identifies baseline to 20 months as the active injection phase and 20 months to 26 months as follow-up, but does not specify the exact primary contrast or provide the values at those times. It is therefore not possible to reconstruct a change estimate.
A mean change also does not describe every participant's course. Participants can have different starting scores and different changes while contributing to the same average. General explanation: a confidence interval, when reported, describes the statistical uncertainty around an estimated quantity under the assumptions of the analysis. It is not a range containing every individual result. No confidence interval or other numerical uncertainty estimate for the primary outcome is reported in the registry record.
Why does the study structure matter?
The study is recorded as single-group, with allocation NA and no masking. General explanation: a randomized comparison can estimate a difference between groups while helping balance other influences, whereas a single-group before-and-after description does not provide that same concurrent comparison. Changes over time can have multiple explanations, and a single-group result alone cannot establish which explanation accounts for a change. Here, the registry record does not report a control group or a randomized contrast.
The study summary refers to a different dosing schedule and a comparison with effects of a standard injection regimen, but the design fields do not describe a second arm. The specified intervention dose is 4 units per injection site over 5 sites. A complete injection schedule is not reported in the registry record. Thus, neither a dose-by-dose schedule nor a comparative analysis can be inferred from the summary wording.
What do the planning assumptions mean?
The record contains planning assumptions for an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect, and says that non-time-to-event results are expressed as participants per arm. These are assumptions for a planning illustration, not a description of the single-group study design. Numerical planning results and the observed effect used for that illustration are not reported in the registry record.
General explanation: a sample-size calculation estimates the amount of information a future design might need to detect a specified effect under stated assumptions. Its output is a planning quantity, not an observed result and not “observed power.” An assumption of equal allocation between two arms does not turn a single-group study into a two-arm comparison. No sample-size justification for the actual study is reported in the registry record.
The registry record lists 2 analyses, but does not report the methods used, the model specification, adjustment variables, handling of repeated measurements, or a test statistic. It also does not provide the numerical endpoint summaries. Without these items, readers cannot reproduce an inferential analysis or assess whether its assumptions were appropriate. General explanation: statistical methods should match the outcome structure and the design; for repeated observations, the analysis needs to account for how measurements from the same participant relate to one another. The record does not say whether or how this was done.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 2 outcome measures and 2 analyses, but the available details do not identify all outcome definitions, distinguish confirmatory from exploratory analyses, or state how many hypotheses were tested. A multiplicity adjustment or a prespecified hierarchy for interpreting multiple outcomes is not reported in the registry record. General explanation: when several outcomes or comparisons are examined, the chance of at least one apparently notable finding can increase. A statistical plan may address this through prespecification or adjustment, but no such approach is described in the available record.
Missing-data procedures are also not reported in the registry record. The enrollment figure is 50, but the number with an FWS measurement at each assessment, the number included in the primary analysis, and reasons for any missing observations are not given. The record does not state whether analyses used all available measurements, restricted attention to participants with complete assessments, or used an imputation method. These choices can affect the result when outcome availability is related to participants’ scores or experiences.
The analysis population is not reported in the registry record. It is therefore unclear whether the endpoint analysis was intended to include everyone enrolled, only participants who received treatment, or another defined group. No interim analyses or stopping rules are reported in the registry record. The absence of these details does not show that particular methods were or were not used; it means the record does not document them. With no numerical endpoint results, sample counts by assessment, or analysis-population definition, the robustness of the primary result cannot be assessed.
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 |
|---|---|---|---|
| Botox | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Botox | 0 of 50 |
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 |
|---|---|
| Botox | 0 of 50 |
The safety record lists 50 participants at risk for serious adverse events and 0 affected by a serious adverse event. It also lists 50 at risk for other adverse events and 0 affected, with 0 deaths. No top serious adverse-event terms are listed. These are the counts recorded for the Botox group.
These entries should be interpreted as registry-recorded counts, not as proof that no event of any kind occurred. In particular, the record reports zero affected for the listed serious and other adverse-event categories; the available information does not describe event definitions, collection procedures, follow-up completeness, or whether all events were captured. The at-risk count does not establish the number with complete safety follow-up.
General explanation: an observed count of zero is an observation within the recorded study, not a guarantee that the underlying risk is zero. Assessing how precisely event risk is characterized also depends on the amount and completeness of follow-up and on how events were defined and collected. Those details are not reported in the registry record. The safety entries therefore describe what was recorded, but do not by themselves establish a comprehensive safety profile or permit comparison with another regimen.
12. What the Result Does, and Does Not, Mean
The registry record identifies a completed Phase 4, single-group study of Botox Cosmetic in participants described in the title as young patients with glabellar furrows. It specifies an FWS outcome, a 26-month timeframe, and a division between an active injection phase and a follow-up phase. It also gives the intervention-site description and records serious adverse-event, other adverse-event, and death counts.
What the record does not establish is the numerical result of the primary endpoint. The mean FWS, standard deviation, estimate of reduction, and uncertainty around that estimate are not reported in the registry record. The study summary states the question of whether a different schedule might lead to longer-lasting effects, but a stated objective is not an outcome. Without the results and the exact analysis contrast, the size and durability of any change cannot be determined.
The single-group design also limits comparative interpretation. It does not provide a randomized control group receiving a standard regimen, and the registry fields record no allocation and no masking. General explanation: a before-and-after pattern can describe change over time, but without a concurrent comparator it cannot isolate the treatment schedule as the cause of that change. The design therefore cannot establish a comparative effect between the described schedule and a standard regimen.
The enrollment count should not be treated as the analysis count. The number of participants contributing outcome data at each assessment and the analysis population are not reported in the registry record. The available safety counts are also limited to the recorded categories and do not supply detailed event collection or follow-up information.
The appropriate reading is therefore bounded: the registry record documents the study's structure, scale, time periods, and recorded safety counts, while leaving the primary numerical outcome and important analysis details unavailable. It supports neither a conclusion of benefit nor a conclusion of no benefit. It also does not justify treating the absence of reported primary results as evidence that no change occurred.
13. Why This Trial Matters Statistically
This study is statistically instructive because its stated question is comparative in spirit—whether a different injection schedule might produce longer-lasting effects—while the registered design is single-group. The distinction matters: the research question can suggest a contrast, but the design fields determine whether that contrast is actually observed. With no recorded randomized control group, the registry does not document a direct comparison with a standard injection regimen.
The time structure also raises an important interpretive issue. The record separates baseline to 20 months as the active injection phase and 20 months to 26 months as follow-up. These periods describe when the study intended to assess treatment and subsequent follow-up, but the schedule of injections and the numerical FWS assessments are not reported in the registry record. Without those data, durability cannot be inferred from the timeframe alone.
The endpoint illustrates the difference between a planned measure and a reported result. A validated scale with defined minimum and maximum scores gives a framework for assessment, and the mean and standard deviation indicate the intended form of summary. Yet an endpoint description cannot substitute for observed values, an analysis contrast, and an uncertainty estimate. The registry record lists none of the numerical primary-outcome results needed to evaluate magnitude or precision.
Finally, the record includes assumptions for sample-size planning that describe a hypothetical two-arm calculation, while the study itself is recorded as single-group. General explanation: planning assumptions are useful only when their design and effect assumptions are clearly distinguished from the design and findings of a completed study. Treating an illustrative calculation as observed evidence would confuse a future-planning quantity with a trial result. This record makes the need for that distinction especially clear.
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 trial-specific limitations restrict interpretation. The most direct is that numerical results for the primary FWS outcome are not reported in the registry record. Without the mean, standard deviation, change estimate, or a measure of uncertainty, the primary finding cannot be described quantitatively. The number contributing data to the outcome is also not reported, so the enrollment figure cannot be taken as the analysis denominator.
The single-group model, allocation marked NA, and absence of masking limit comparative interpretation. There is no registered randomized control group to distinguish change during the study from change that might have occurred under another regimen. Although the summary frames the study around a different dosing schedule and longer-lasting effects, the detailed injection schedule and comparative contrast are not reported in the registry record.
Other important details are also unavailable: participant eligibility criteria beyond the condition and title description, the analysis population, missing-data handling, the statistical model, the precise primary comparison, and methods for addressing multiple outcomes or analyses. The record does not explain how FWS assessments were conducted or who performed them. These omissions prevent assessment of how fully the reported design and analysis address potential sources of bias or uncertainty.
The safety entries report zero affected for the listed serious and other adverse-event categories and zero deaths, but event definitions, ascertainment methods, and safety follow-up completeness are not reported in the registry record. The figures should not be generalized beyond those recorded categories and counts. Taken together, these limitations mean that the registry supports a description of study conduct at a high level, but not a complete appraisal of efficacy, durability, or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Botox Cosmetic and the Young Patient With Glabellar Furrows — NCT00856999.
- Registry record last updated 2019-07-23; status last verified 2019-07.
- Results first posted 2019-07-23.
- 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 NCT00856999, “Botox Cosmetic and the Young Patient With Glabellar Furrows,” as a completed Phase 4, single-group study sponsored by Oregon Health and Science University. Enrollment was 50. The intervention description specifies Botox Cosmetic at 4 units per injection site over 5 sites, treating the procerus and corrugator superciliaris muscle groups. Allocation is listed as NA, and masking as none.
The primary outcome was reduction of the FWS, measured in units on a scale, with a 26-month timeframe. The scale is described as ranging from 0 for no wrinkles to 3 for deep wrinkles. Baseline to 20 months is identified as the active injection phase, followed by a 20-to-26-month follow-up phase. Numerical primary-outcome results and analysis details are not reported in the registry record.
The safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths. These counts describe the registry entries and do not replace details about event ascertainment or follow-up, which are not reported in the registry record.