U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne (NCT01706263), a na phase 4 study. The primary outcome is Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8.

2. Clinical Question

The study description frames adherence, tolerability, cost, availability, and ease of use as considerations in acne therapy. Its stated purpose was to evaluate efficacy and tolerability of the over-the-counter topical product line. However, the listed primary endpoint concerns facial lesion counts, while the registry also lists tolerability assessments and other outcomes. An open-label, single-group design can describe changes occurring during use, but it cannot separate effects of the regimen from changes that might have occurred over time or from other influences. Because no comparative group is recorded, the study does not directly answer whether the regimen performs better or worse than an alternative.

3. Trial Design

The registry describes U0289-402 as a Phase 4, open-label, 8-week, single-group study of MAXCLARITY II in people with acne. Enrollment is recorded as 28. The study status is completed; the recorded start date is 2009-08-01 and the primary completion date is 2009-11-20. These dates describe the registry record and do not, by themselves, establish when any participant began or finished treatment.

Allocation is listed as not applicable, masking as none, and the model as single group. Participants therefore were not assigned among recorded treatment arms for a controlled comparison, and treatment was not masked. The intervention description includes three products: a 2.5% benzoyl peroxide foam cleanser, a 2.5% benzoyl peroxide foam treatment, and a 0.5% salicylic acid toner foam. The record describes these products together as the MAXCLARITY II regimen, available over the counter.

The primary endpoint is mean percent change in inflammatory, non-inflammatory, and total lesion counts from baseline to Week 8. Baseline is defined as the Day 1 value. Lesions were assessed on the face, with inflammatory lesions comprising papules and pustules and non-inflammatory lesions comprising open and closed comedones. The registry also lists assessments of lesion counts at earlier visits, investigator global assessment, improvement in global assessment grade, and investigator and participant tolerability assessments.

The design is suited to recording within-group observations during product use, but without a comparator it cannot estimate a between-treatment contrast. The record does not report a protocol, detailed treatment-use instructions, adherence measurements, or a statistical analysis plan. It also does not explain how the description of the analysis population as including randomized participants relates to the single-group design.

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

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat analysis set was used which included data from all randomized participants who received study product.

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.

6. Primary Endpoint

The registry lists the primary outcome as Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8, measured over Baseline (Day 1) and Week 8.

The primary endpoint is mean percent change from baseline to Week 8 in inflammatory, non-inflammatory, and total facial lesion counts. The evaluator counted lesions on both sides of the face, from the hairline to the mandible, including the forehead, cheeks, and chin. Inflammatory lesions were papules and pustules; non-inflammatory lesions were open and closed comedones. Total lesions were defined as the sum of inflammatory and non-inflammatory counts.

For each lesion category, the registry defines percent change using the Week 8 value minus the baseline value, divided by the baseline value, and multiplied by 100. Baseline is the Day 1 value. The outcome is a continuous measure summarized as a mean, with standard deviation identified as its dispersion measure. A percent-change measure expresses change relative to each participant’s baseline count, rather than reporting only the raw number of lesions gained or lost. The mean then describes the average of those participant-level changes in the analysis population.

Lesion counts are used to quantify visible acne features in specified categories and can track change over the study period. The separate categories matter because inflammatory and non-inflammatory lesions are not the same clinical observation; the total count combines them. The registry record does not report baseline means, Week 8 means, mean percent changes, standard deviations, or confidence intervals. Accordingly, it identifies what was intended to be measured, but not the observed magnitude or precision of the endpoint results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation begins with the structure of the endpoint and the study. The primary outcome is continuous: each participant has a percent change in lesion count, and the registry identifies a mean and standard deviation as the summary measures. A mean describes the average participant-level value. A standard deviation describes how spread out individual values are around that mean; it is not the uncertainty of the estimated mean. The registry record identifies this summary approach but does not report its numerical results.

What does percent change represent?

Percent change places the change in lesion count in relation to the participant’s baseline count. The registry’s definition uses the Week 8 value minus the baseline value, divided by baseline, and multiplied by 100. The sign and size of a participant’s value depend on the change relative to that participant’s baseline. Averaging participant-level percent changes gives a summary across the analysis population. That summary is different from calculating a percent change from group-level average counts; those approaches need not give the same result. The registry describes the endpoint formula, but does not provide the underlying counts or endpoint estimates needed to inspect the calculation.

Percent change also has interpretive constraints. It depends on the baseline value, and a given raw change can represent different relative changes for different starting counts. If baseline values are small, relative measures can be especially sensitive to modest raw changes. This is a general property of percent-change measures, not a claim about the baseline distribution in this study. Baseline counts and their distribution are not reported in the registry record.

What does a confidence interval add?

A confidence interval is a range of values compatible with the data and the statistical model used to estimate an outcome. In general, a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. An interval around a mean percent change would help readers assess the uncertainty of the estimated average, alongside the mean and standard deviation. No confidence interval for the primary endpoint is reported in the registry record. Therefore, neither the precision nor the range of plausible average changes can be assessed from the record.

A confidence interval is not a guarantee that the true value lies within the particular calculated range, nor does it address every source of bias. It reflects sampling uncertainty under the analysis assumptions. It cannot compensate for the lack of a control group, open-label assessment, or unreported missing-data handling. These are distinct concerns: precision describes uncertainty in an estimate, whereas design and measurement limitations affect how the estimate should be interpreted.

Why does the single-group design matter?

In a controlled trial, a treatment contrast compares outcomes between groups under the study’s allocation scheme. This record instead lists one group and no allocation. A change from baseline can be described, but there is no randomized between-group comparison to distinguish a treatment-associated change from temporal changes or other influences. General statistical adjustment cannot create the missing randomized control comparison. The record does not report a prespecified external comparator or a model intended to address this limitation.

Open-label means masking is listed as none. For a count-based endpoint, a defined assessment procedure helps standardize what is counted, but knowledge of treatment can still be relevant to how assessments are conducted. The registry description gives lesion definitions and facial boundaries. It does not report assessor masking, duplicate assessments, reliability checks, or other procedures for quantifying measurement variability.

How should dispersion and over-dispersion be understood?

The registry identifies standard deviation for the mean continuous endpoint. Standard deviation is a descriptive measure of variation among observations. It should not be confused with a standard error or a confidence interval. Lesion counts themselves are counts, and count data can sometimes vary more than a simple count model assumes. In general, over-dispersion means that observed variability exceeds what a particular model expects; methods that account for it can help avoid understating uncertainty. The registry record does not report a count-data model, an over-dispersion assessment, or a model-based analysis for the primary endpoint. The endpoint is defined as percent change and summarized by a mean, so no count-model assumptions should be inferred from that description alone.

The record’s sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such calculations are planning illustrations rather than observed power. They do not change the single-group design of this study, and a two-arm planning scenario should not be mistaken for a treatment comparison conducted in the trial. The record does not report a sample-size justification for the actual study or explain how any planning illustration relates to its design. The observed primary effect and its dispersion are not reported in the registry record, so the underlying endpoint evidence cannot be evaluated in the registry record.

More generally, a planned power calculation concerns the probability that a specified design and analysis would detect an effect of a stated size under its assumptions. It is not a measure of the probability that a result is true, and it cannot substitute for observed estimates and uncertainty. Once results are observed, interpretation should focus on the estimated outcome, its precision, the design, and the completeness of reporting. No hypothesis-test results for the primary endpoint are reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several outcomes and assessment visits: lesion-count changes, investigator static global assessment, improvement by at least one grade, and investigator and participant tolerability assessments. Testing or interpreting many outcomes can raise a multiplicity concern because multiple comparisons may increase the chance of at least one apparently notable result. A prespecified hierarchy or multiplicity adjustment can address some such concerns, but the statistical plan and any multiplicity procedure are not reported in the registry record. The record does not identify which secondary outcomes, if any, were treated as confirmatory.

Missing-data handling is also not reported in the registry record. The record does not specify how participants without a Week 8 assessment were handled, whether outcome values were imputed, or how incomplete visits affected each analysis. The enrollment figure alone does not establish how many participants contributed to a particular endpoint, so no endpoint denominator can be inferred from it.

The primary analysis population is described as an intent-to-treat analysis set including data from all randomized participants who received study product. The study is also recorded as single-group with allocation not applicable. The registry record does not explain how the randomized-participant wording applies to this design, nor does it provide details about exclusions or analysis-population implementation. This makes the population definition difficult to evaluate fully without additional documentation.

Interim analyses and the broader statistical analysis plan are not reported in the registry record. Their absence from the registry description should not be taken as evidence that a particular procedure was or was not used; the record simply does not document it. These reporting gaps limit assessment of analysis choices and of whether outcome reporting followed a prespecified plan.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports safety counts for the MAXCLARITY II group. Serious adverse events are recorded as affecting 0 participants, with 28 at risk; deaths are recorded as 0. Other adverse events are recorded as affecting 11 participants, with 28 at risk. These are counts, not rates calculated for comparison with another group. The record does not provide a control group or comparative safety estimate.

A zero count means that no event of that category was recorded in this study group under the registry’s reporting. It does not mean the risk is zero, and it cannot rule out uncommon events. The study was limited in size and follow-up duration, so its safety counts describe observations in this setting rather than establishing the full safety profile of the products. No confidence interval or other uncertainty estimate for the safety counts is reported in the registry record.

The record does not list serious adverse-event terms. The registry entries available for interpretation also do not give the specific terms or severity details for the other adverse events. Therefore, the count of 11 affected participants cannot be used to describe the nature, timing, duration, or relationship of those events to treatment. It should not be interpreted as a count of events, since the reported figure is participants affected. These descriptive data do not establish whether the regimen caused an event or whether its frequency differs from that under another treatment.

12. What the Result Does, and Does Not, Mean

This study addresses a focused descriptive question: what happened to facial lesion counts during an 8-week course of the MAXCLARITY II regimen in an open-label, single-group setting? The registry defines how inflammatory, non-inflammatory, and total lesions were assessed and how the primary percent-change outcome was calculated. It also identifies secondary assessments of global acne status and tolerability. Those details clarify the planned measurements, but the primary and secondary outcome results are not reported in the registry record.

As a result, the available record does not establish the average change in lesion counts, the variability between participants, or the precision of the estimate. It also does not show whether any observed change, if reported elsewhere, would be attributable to the regimen. A single-group before-and-after observation lacks the concurrent comparison needed to separate changes associated with treatment from other changes over time. Open-label assessment is another consideration when outcomes depend on evaluation.

The safety counts offer limited descriptive information: the record reports no serious adverse events or deaths and reports 11 participants affected by other adverse events. These figures are not comparative evidence and do not identify the specific non-serious events. The data cannot establish that an event was caused by the products, nor can a lack of recorded serious events establish absence of risk.

Accordingly, the registry record supports an account of study design, endpoints, and reported safety counts, but not a conclusion about the magnitude or clinical importance of efficacy outcomes. It cannot establish comparative benefit, superiority, or equivalence to another option. Such conclusions would require relevant outcome estimates and uncertainty, as well as a design capable of supporting the comparison. The missing numerical endpoint results are an important limit on what can be concluded from this registry record.

13. Why This Trial Matters Statistically

This study is statistically useful to examine because it illustrates how the research question, design, endpoint, and reporting determine what an estimate can mean. The primary endpoint is carefully described in terms of lesion types, facial area, timing, and a percent-change calculation. That specificity helps readers understand what was intended to be measured. Yet measurement detail alone does not provide evidence about the observed effect: numerical outcome results and measures of uncertainty are not reported in the registry record.

The single-group design also makes the distinction between change and treatment effect especially important. Within-group change can be summarized statistically, but without a comparator it cannot isolate the regimen’s contribution. A precise estimate of change, even if one were available, would not resolve this design limitation. Conversely, the lack of reported outcome estimates prevents assessment of precision as well as magnitude.

The case also highlights the importance of transparent analysis details. The record identifies a mean and standard deviation for a continuous endpoint and gives an analysis-population description, but does not document missing-data methods, multiplicity handling, or the wider analysis plan. Without these details, readers cannot fully evaluate the assumptions underlying analysis or how all planned outcomes were handled. The mismatch between single-group design and randomized-participant wording is another reason to consult additional documentation if available.

Finally, safety counts should be interpreted according to their evidential scope. They describe events recorded in this study group and cannot establish a comparison or exclude uncommon harms. Statistical reading is therefore not just a matter of looking for a numerical result; it requires asking what was compared, how the outcome was measured, what uncertainty was reported, and what information remains absent.

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 study record. It describes an open-label, single-group design with no allocation and no comparator. Consequently, any within-group change would not provide a controlled estimate of the regimen’s effect. Knowledge of treatment also was not masked, and the registry record does not describe assessor masking or procedures to evaluate consistency of lesion counting.

The primary endpoint is based on facial lesion counts and percent change from baseline. The registry defines lesion categories and the facial area assessed, but does not report baseline distributions or numerical results. Percent change depends on baseline values, and the record does not give enough information to assess how baseline variation influenced the group summary. Standard deviation is named as the dispersion measure, but its value and any confidence interval are not reported.

The record does not report the handling of missing outcome data, the actual number contributing to each assessment, or a statistical analysis plan. It also does not describe adherence, product use over time, or how deviations from the intended regimen were managed. Because the study description emphasizes adherence and tolerability as considerations, the absence of reported adherence results limits assessment of how product use related to outcomes.

The analysis population is described using randomized-participant language, while the design is recorded as single-group with allocation not applicable. The record does not reconcile these descriptions. Finally, the registry reports safety counts without details of the other adverse-event terms and does not report comparative safety data. These limitations constrain interpretation and cannot be resolved by the endpoint definitions alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne — NCT01706263.
• Registry record last updated 2018-01-08; status last verified 2018-01.
• Results first posted 2018-01-08.
• 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.

18. Record Summary

The record describes NCT01706263, a completed Phase 4, open-label, single-group study of MAXCLARITY II in acne vulgaris. Enrollment is recorded as 28. The regimen comprised a 2.5% benzoyl peroxide foam cleanser, a 2.5% benzoyl peroxide foam treatment, and a 0.5% salicylic acid toner foam. The primary endpoint was mean percent change in inflammatory, non-inflammatory, and total facial lesion counts from baseline to Week 8.

The registry record does not report numerical primary or secondary outcome results, confidence intervals, or hypothesis-test results. It records 0 participants with serious adverse events, 0 deaths, and 11 participants affected by other adverse events. There was no comparator group. The missing outcome estimates and the single-group open-label design prevent a comparative assessment of efficacy, while the safety counts remain descriptive.