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 RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients (NCT05386368), a randomized phase 4 study. The primary outcome is Change in Skin Sensitivity Scores - Redness.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05386368 |
| Phase | Phase 4 |
| Condition | Carbon Dioxide Laser, Photoaging |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Triple |
| Enrollment | 1 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
Cosmetic patients receiving carbon dioxide (CO2) laser treatment are the intended population in the record. The stated condition includes photoaging. Enrollment was 1, so the posted results represent a very limited study population.
Intervention
The intervention is ReCell, described as an autologous cell suspension obtained through enzymatic and mechanical preparation. The record describes application to a perioral area after CO2 laser treatment. Its brief summary says the study sought to determine whether this approach could reduce negative side effects and shorten healing time.
Comparator
The arm descriptions refer to saline on the opposite perioral side. One description assigns ReCell to the right side and saline to the left; the other reverses the sides. However, the record also identifies the model as single-group, and the posted outcome data include a participant only in the right-side ReCell arm. There is no participant represented in the other described arm.
Primary question
The primary outcome is the number of participants reporting that redness was “not at all” at month 3, on a survey scale that also includes “a little,” “moderately,” and “extremely.” The posted result is 1 participant in the right-side ReCell arm and no participants in the left-side ReCell arm. With no participants in the latter arm, the record cannot provide a supported comparison between the two described assignments.
3. Trial Design
The registry record describes a Phase 4 study with randomized allocation and triple masking. It also identifies the study model as single-group. These design labels appear alongside two arm descriptions: one places ReCell on the right perioral area and saline on the left, while the other places ReCell on the left and saline on the right. The record does not explain how these features fit together, so the intended allocation structure cannot be resolved from the entry alone.
The listed sponsor is Wake Forest University Health Sciences. The record gives a study start date of 2023-03-22 and a primary completion date of 2023-07-07. Its status is terminated, and enrollment is 1. The record does not state why the study was terminated or provide details about the timing or circumstances of the one participant’s enrollment.
The intervention is named ReCell and categorized as a drug. The brief summary describes an autologous cell suspension prepared enzymatically and mechanically, applied after CO2 laser treatment. Saline is named in the arm descriptions as the treatment on the opposite side. The registry record does not give further procedural details in the information.
The posted primary outcome is a count of participants reporting redness as “not at all” at month 3. One participant is listed in the right-side ReCell arm, with a reported value of 1; the left-side ReCell arm has 0 participants and no reported value. No analyses are posted. A secondary outcome is listed as healing within 2 weeks post-op, but the record does not provide a result for it. The design and outcome entries therefore describe the question and planned structure more clearly than they establish an evaluable comparative trial.
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 | Right Receives ReCell (A) | Left Receives ReCell (B) |
|---|---|---|
| STARTED | 1 | 0 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: We did not have any subjects that received (B) Left receives Recell
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: We only had one subject total and she received (A) Right receives Recell
| Characteristic | Unit | Right Receives ReCell (A) | Left Receives ReCell (B) | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | |
| Age, Categorical: <=18 years | Participants | 0 | — | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | — | 0 |
| Age, Categorical: >=65 years | Participants | 1 | — | 1 |
| Age, Continuous | years | 71 (71 to 71) | — | 71 (71 to 71) |
| Sex: Female, Male: Female | Participants | 1 | — | 1 |
| Sex: Female, Male: Male | Participants | 0 | — | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | — | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | — | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | 0 |
| Region of Enrollment: United States | participants | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Skin Sensitivity Scores - Redness, measured over month 3.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | # of participants reporting not at all |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint counts participants who selected “not at all” for redness at month 3. The survey response scale also includes “a little,” “moderately,” and “extremely.” This endpoint captures a participant-reported symptom at a specified follow-up time rather than a continuous measurement of redness or a direct measure of wound closure.
A category-based outcome can be useful when the research question concerns how participants experience a symptom. It makes the response options understandable, but it also compresses a range of experiences into categories. The posted primary measure focuses specifically on the “not at all” category; the record does not show the distribution across the other response categories.
The study’s brief summary also refers to reducing negative side effects and decreasing healing time. The primary endpoint addresses redness, while a secondary outcome is listed as healing within 2 weeks post-op. These are distinct concepts: a symptom rating does not itself establish a healing time, and a healing outcome does not directly describe redness. The registry record does not provide a primary endpoint result for healing time.
The posted redness result is a count of 1 in the right-side ReCell arm, which has 1 participant. There are no participants in the left-side ReCell arm and its value is unavailable. This is a descriptive observation from a single participant, not an estimate of a comparative effect. No uncertainty interval or inferential analysis is posted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome reports that 1 participant in the right-side ReCell arm selected “not at all” for redness at month 3. That arm has 1 participant. The other described arm has 0 participants and no reported outcome value. The result therefore records a response in the participant who was represented; it does not show how redness responses differed between the two described assignments.
The absence of participants in the second arm is central to interpretation. A comparative trial needs outcome information from both conditions to estimate a between-condition contrast. Here, a comparison is not estimable from the posted data. This does not mean the two conditions had the same result, nor does it mean the comparison favored either condition. The data for one side of that contrast are absent because there were no participants in that arm.
The record reports no analyses. It does not post a treatment-effect estimate, a confidence interval, a p-value, or an adjustment for any covariates. There is consequently no inferential result to interpret. The value of 1 is a count, not a treatment-effect estimate. It should not be read as evidence of a population response rate or as a measure of precision.
More generally, a confidence interval describes a range of values compatible with the data and the analysis assumptions; narrower intervals indicate greater precision. No confidence interval is reported, and the sparse posted data do not support constructing a comparative interval from the information available. A p-value, when appropriate, addresses compatibility of data with a specified null model; it does not measure the size or clinical importance of an effect. No p-value is posted.
The record lists a secondary outcome of healing within 2 weeks post-op, but no result for that outcome is included in the posted data. It also indicates seven outcome measures and zero analyses. Those entries mean that readers should not infer that all outcome measures were completed, analyzed, or reported. The single posted primary result cannot answer the study’s broader stated question about side effects and healing time.
The record’s terminated status and enrollment of 1 further define the scope of the evidence. The reason for termination is not reported in the registry record. Without an explanation, readers cannot determine whether the enrollment reflects recruitment difficulty, a decision based on circumstances outside the study, or another reason. None should be assumed. In short, the posted result is a record of one participant’s redness response at month 3, with no comparative or inferential conclusion available.
9. Statistical Methods Explained
The registry entry identifies the allocation as randomized, masking as triple, and model as single-group. It also gives two arm descriptions that assign ReCell and saline to opposite sides of the perioral area. These labels do not, on their own, explain the operational design. The record does not report who was masked, how the random assignment was carried out, or how the single-group model relates to the two descriptions. Those details are not reported in the registry record.
What does the posted count represent?
The primary measure is a count of participants whose redness response was “not at all” at month 3. Counts are direct summaries of how many observations fall into a category. They do not, by themselves, describe uncertainty or establish a difference between conditions. The record gives a count of 1 for the right-side ReCell arm and lists 1 participant in that arm. For the left-side ReCell arm, it lists 0 participants and no value. A missing value in an arm with no participants is not an observed response of zero; it is an unavailable arm result.
Why is a two-arm estimate unavailable?
A comparative estimate requires data for both conditions in the comparison. When one described arm contains no participants, a contrast between arm outcomes cannot be calculated from the posted results. This is why the record’s comparison is not estimable. General statistical methods can sometimes compare paired sides within the same person, but the registry entry does not provide the paired data or an analysis of that kind. It would be inappropriate to assume that a paired analysis was performed.
General statistical practice also distinguishes a descriptive result from an inferential result. A descriptive result summarizes the observations actually posted. An inferential analysis uses a statistical model to quantify uncertainty or assess a specified hypothesis. The record reports no analyses, so the result should be read descriptively. There is no reported standard error, confidence interval, or hypothesis test.
What do confidence intervals and over-dispersion mean?
In general, a confidence interval expresses uncertainty around an estimated quantity under a stated analysis and its assumptions. It does not guarantee that the true value lies in the interval, and it does not replace consideration of study design or data quality. No confidence interval is reported for this endpoint. A comparative interval cannot be recovered from the single-arm count alone.
Over-dispersion is a general issue for count data: it occurs when observed variability is greater than a model assumes. It can make model-based uncertainty estimates too small if it is ignored. That concept is relevant to some analyses of counts, but the registry record does not report a count model, dispersion estimate, or inferential analysis. The posted measure is a participant count in a response category, and no model-based conclusion should be attributed to it.
How should planning illustrations be read?
The page includes calculated planning illustrations based on an observed effect and describes assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such figures are hypothetical planning quantities, not observed study results and not observed power. The record does not report the trial’s own sample-size justification or design calculation. In this case, the posted data do not support a two-arm effect estimate, so any planning illustration should not be mistaken for evidence that the study had adequate enrollment or that a particular effect was established.
In general, a planning calculation asks how many participants might be needed under specified assumptions to detect a chosen effect with a chosen level of statistical power. It depends on those assumptions, including the effect size and outcome variability. It does not tell readers the probability that the observed study result is correct. Nor does it show that the study was designed using those assumptions. The trial’s own protocol-based sample-size rationale is not reported in the registry record.
What analysis plan is visible?
The registry record reports zero analyses. It does not describe an analysis population, a statistical model, covariate adjustment, handling of repeated measurements, or an approach to missing data. These omissions limit reproducibility and prevent assessment of whether the posted endpoint followed a prespecified analysis plan. A registry entry can describe outcomes and arms without containing a full statistical analysis plan; readers should not fill in that missing information by assuming customary methods.
10. Multiplicity, Missing Data and Analysis Populations
The record lists seven outcome measures and one posted secondary outcome, healing within 2 weeks post-op. The primary outcome is redness at month 3. The information does not provide the complete outcome list or results for every measure. It also reports zero analyses. The planned hierarchy among outcomes, if any, is not reported in the registry record.
Multiplicity arises when several outcomes, time points, subgroups, or statistical tests are evaluated. In general, examining more results can increase the chance of finding an apparently notable result by chance. A prespecified testing hierarchy or adjustment can address some multiplicity concerns, but neither a multiplicity strategy nor a complete statistical analysis plan is reported. Since no analyses are posted, there is no set of reported hypothesis tests for which an adjustment can be assessed.
The outcome data are highly limited: the right-side ReCell arm lists 1 participant, while the left-side ReCell arm lists 0. The registry record does not explain whether the second arm was unfilled, whether outcome data were unavailable for a planned participant, or why the study ended with enrollment of 1. It is therefore not possible to classify the absent arm result as a particular type of missingness or to assess whether missingness may have affected the result.
The record also does not report an analysis population, participant flow, exclusions, protocol deviations, or how incomplete survey responses were handled. These details matter because a reader needs to know who was eligible for analysis and whether the reported outcome reflects all enrolled participants. No imputation or other missing-data procedure is described. The posted count should therefore be interpreted only as the result listed for the represented arm, without assuming how unreported observations were handled.
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 |
|---|---|---|---|
| Right Receives ReCell (A) | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Right Receives ReCell (A) | 0 of 1 |
| Left Receives ReCell (B) | 0 of 0 |
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 |
|---|---|
| Right Receives ReCell (A) | 0 of 1 |
| Left Receives ReCell (B) | 0 of 0 |
The safety summary lists 0 serious adverse events among 1 participant at risk in the right-side ReCell arm. It lists 0 other adverse events among the same 1 participant at risk, and 0 deaths. For the left-side ReCell arm, the number at risk is 0; the record lists 0 events and 0 deaths for that arm as well.
These figures are counts within the posted safety groups. The left-side group has no participants at risk, so its zero event count does not represent an observed period without events among participants. In the right-side group, the absence of a reported event is an observation in a group of 1 participant. It does not establish that events cannot occur or provide a precise estimate of event frequency in a broader population.
The registry record does not list serious adverse event terms. The counts also do not provide details about event timing, severity beyond the serious-versus-other grouping, relatedness, or follow-up completeness. Zero reported events should therefore be read as the posted count, not as proof of no safety risk. The small enrollment and empty second group sharply limit what these figures can establish.
12. What the Result Does, and Does Not, Mean
The posted primary result means that the one participant represented in the right-side ReCell arm reported redness as “not at all” at month 3. The registry record has no participant in the other described arm and no value for that arm. This is an observation about the posted record, not a comparative finding.
The result does not establish whether ReCell changes redness relative to saline. There is no participant-level result from the saline side available for comparison in the posted outcomes, and no analysis is reported. The result also does not establish that ReCell shortens healing time: healing within 2 weeks post-op is listed as a secondary outcome, but its result is not included. Nor does a redness category capture every possible side effect described in the study’s brief summary.
The record does not provide a confidence interval or other estimate of uncertainty. Consequently, the precision of any treatment effect cannot be assessed, and no effect estimate should be inferred from the single count. A lone response may be important as an individual observation, but it cannot characterize the range of outcomes among cosmetic patients receiving CO2 laser treatment.
Similarly, the safety counts do not demonstrate absence of risk. They describe the recorded events in a very limited enrolled group, with no participants in one of the listed arms. The trial’s terminated status is reported, but the reason is not reported in the registry record. The available information cannot establish what led to termination or what additional data might have been collected outside the posted results.
Overall, this record documents the study’s objective, design labels, outcome definitions, and a very limited set of results. It does not provide an evaluable comparison or an inferential answer to its treatment question. These distinctions allow readers to acknowledge exactly what was recorded without treating the result as evidence for or against a treatment effect.
13. Why This Trial Matters Statistically
This trial matters statistically because its record illustrates the difference between a stated comparative question and data that can answer it. The arms describe ReCell and saline applied to opposite perioral sides, but the posted outcomes include a participant only in one described arm. Without outcome data in both conditions, the central comparative estimate is not available.
It also shows why enrollment and analysis denominators must be read together. The primary value is a count, and the corresponding arm has 1 participant. The other arm has 0 participants and no value. A count without its denominator can be misleading; even with the denominator visible, the observation remains too limited to support a population-level comparison.
The registry’s design labels deserve attention as well. Randomized allocation and triple masking are listed, yet the study model is identified as single-group and two arm descriptions appear. Design labels are not a substitute for an account of how allocation, masking, and analysis were implemented. When these pieces are not reconciled, readers cannot confidently reconstruct the intended comparison.
Finally, the record distinguishes outcome registration from outcome analysis. Seven outcome measures are indicated, while zero analyses are reported. A listed outcome is not the same as a reported result, and a reported count is not the same as an inferential analysis. The terminated status, limited enrollment, and absence of a reported sample-size justification further show why readers should separate a study’s rationale from the evidence actually available.
These are broadly useful statistical reading habits: identify the unit of observation, check who contributes to each group, distinguish descriptions from comparisons, and look for the analysis and uncertainty information needed to support inference. Here, those checks clarify the narrow scope of the posted result.
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 main limitation is enrollment of 1, alongside a posted arm size of 1 for right-side ReCell and 0 for left-side ReCell. This leaves no outcome information for one of the described assignments and prevents a two-arm comparison. The primary result is consequently a single participant’s category response rather than a comparative estimate.
The registry record’s design description is difficult to reconcile: it states randomized allocation and triple masking, identifies a single-group model, and lists two side-specific arm descriptions. It does not explain how the assignments were implemented or how the model designation relates to those arms. Details about the masking roles and allocation procedure are not reported in the registry record.
The study is listed as terminated, but the reason is not reported in the registry record. The entry gives a primary completion date, yet does not explain the circumstances around the study’s completion or how the recorded enrollment relates to its intended recruitment. The trial’s own sample-size justification and statistical analysis plan are also not reported.
The available result is limited to the redness category “not at all” at month 3. The record does not give the responses in the other categories or a primary outcome analysis. Although healing within 2 weeks post-op is listed as a secondary outcome, its result is not included. The broader set of outcome measures and their results cannot be assessed from the information available.
Finally, there are no posted analyses, confidence intervals, or p-values, and the record does not describe missing-data handling or analysis populations. Safety counts are similarly limited by enrollment and the empty arm. These limitations preclude claims about comparative effectiveness, precision, or safety beyond the posted descriptive counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: RECELL to Promote Healing Following Carbon Dioxide (CO2) Laser Treatment in Cosmetic Patients — NCT05386368.
- Registry record last updated 2024-08-09; status last verified 2024-03.
- Results first posted 2024-08-09.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a Phase 4, randomized, triple-masked study of ReCell after CO2 laser treatment in cosmetic patients. It lists a single-group model alongside two side-specific arm descriptions involving ReCell and saline. The sponsor is Wake Forest University Health Sciences; the status is terminated, and enrollment is 1.
The primary outcome counts participants reporting redness as “not at all” at month 3. The right-side ReCell arm has 1 participant and a reported count of 1. The left-side ReCell arm has 0 participants and no reported value. No analyses are posted. Healing within 2 weeks post-op is listed as a secondary outcome, but no result is included.
The record reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the group with 1 participant at risk; the other group has 0 participants at risk. These are descriptive counts and do not support a comparative or population-level conclusion. The reason for termination, the trial’s own sample-size justification, and a detailed analysis plan are not reported in the registry record.