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 Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin. (NCT01909713), a na phase 4 study. The primary outcome is Cutaneous Tolerability Based on Visual Inspection - Erythema.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01909713 |
| Phase | Phase 4 |
| Condition | Acne Prone Skin |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 7–11 with acne-prone skin. The registry record lists an enrollment of 35.
Intervention
Use of Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Comparator
There was no separate comparator group. The study is recorded as single-group, with allocation listed as NA and masking listed as NONE.
Primary question
At Week 3, what was the observed cutaneous tolerability based on visual inspection for erythema? The endpoint is specified, but its outcome values are not reported in the registry record.
The study’s stated purpose was to determine the tolerability of the cleanser and moisturizer regimen in pediatric subjects with acne-prone skin. The central question is therefore about observed skin redness during use, rather than a comparison of the regimen with another product or with no treatment.
The registry describes erythema as assessed by an investigator using a severity scale, with assessments at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). The primary outcome timeframe is listed as Week 3. The record does not report the numbers of participants in each erythema category at those visits or a summary of the Week 3 result. It is consequently not possible to quantify the observed primary endpoint from the registry record.
Other listed outcomes concern itching, burning, stinging and tightness reported through interviews with subjects and parents or legally authorized representatives, as well as barrier function, hydration and satisfaction with the face wash and moisturizer. These outcomes broaden the tolerability assessment, but their results are not reported in the registry record. Because there is no comparator group, the study does not directly estimate how outcomes would differ under another regimen.
3. Trial Design
The record identifies this as a completed Phase 4, single-group study sponsored by Galderma R&D. Enrollment was 35. The study started in 2013-05 and primary completion was in 2013-06. Its stated purpose was to assess tolerability in children aged 7–11 with acne-prone skin.
All subjects used the Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. The intervention is recorded as a facial cleanser and moisturizer SPF 30. The study has no separate control arm: allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. Thus, the design is not a randomized comparison, and any observed changes cannot be contrasted with outcomes in a concurrent control group.
The primary endpoint is cutaneous tolerability based on visual inspection for erythema at Week 3. The description says assessments took place at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). The severity scale ranges from 0, meaning no observable redness, to 4, meaning severe redness with edema; the intermediate descriptions progress from very mild through moderate. The registry does not state how these repeated assessments were combined into a single primary analysis.
Secondary outcomes include interview-based reports of itching, burning, stinging and tightness; transepidermal water loss (TEWL) as a barrier-function measure; corneometry for hydration; and satisfaction questionnaires for the face wash and moisturizer. The record lists 12 outcome measures, but does not provide outcome-level analysis counts: the recorded number of analyses is 0. The statistical analysis plan, sample-size justification, handling of repeated observations and analysis population are not reported in the registry record.
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 | Cetaphil® DermaControl™ Regimen. |
|---|---|
| STARTED | 35 |
| COMPLETED | 35 |
| NOT COMPLETED | 0 |
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 | Cetaphil® DermaControl™ Regimen. |
|---|---|---|
| Participants analysed | 35 | |
| Age, Continuous | years | 9.0 (SD 1.5) |
| Age, Customized | years | 9.0 (7.0 to 11.0) |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 18 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 |
| Race (NIH/OMB): White | Participants | 22 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 12 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Normal Skin Type | participants | 35 |
| Fitzpatrick Skin Type: II | participants | 7 |
| Fitzpatrick Skin Type: III | participants | 5 |
| Fitzpatrick Skin Type: IV | participants | 3 |
| Fitzpatrick Skin Type: V | participants | 12 |
| Fitzpatrick Skin Type: VI | participants | 8 |
| Global Severity of Acne: Clear | participants | 1 |
| Global Severity of Acne: Almost Clear | participants | 27 |
| Global Severity of Acne: MIld | participants | 7 |
| Oiliness Evaluation Score: Not Oily | participants | 28 |
| Oiliness Evaluation Score: Mildly Oily | participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Cutaneous Tolerability Based on Visual Inspection - Erythema, measured over Week 3.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is cutaneous tolerability based on visual inspection for erythema, with the primary timeframe listed as Week 3. Erythema means observable skin redness. The investigator’s scale distinguishes no observable redness from increasingly severe redness, ending at severe redness with edema. The record says erythema was assessed at visit 1 (day 1), visit 2 (day 8) and visit 3 (day 22).
Visual inspection provides a structured way to record a sign of skin irritation during product use. A graded scale preserves distinctions in severity that would be lost in a simple present-or-absent classification. It can therefore describe both whether redness was observed and how pronounced the investigator judged it to be. However, a scale score is an assessment, not by itself an explanation of why redness occurred or whether it was caused by the regimen.
The endpoint is stated in participants, and the parameter is listed as NUMBER. The registry record does not report the number of participants at each score, the distribution of scores, or a numerical summary at Week 3. It also does not describe an analysis rule for using the assessments from the separate visits. The endpoint definition is available, but its observed result and the method used to summarize it are not reported in the registry record.
The additional interview-based tolerability outcomes can capture sensations that may not be apparent from visual inspection. Barrier function and hydration assess other skin characteristics, while satisfaction questionnaires address subjects’ views of the products. Those outcomes complement the primary endpoint but do not replace the missing numerical erythema result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question, design, regimen and intended primary measure, but does not report the primary endpoint values. Although erythema was assessed at visit 1 (day 1), visit 2 (day 8) and visit 3 (day 22), the registry does not state how many participants had each severity score or give a summary for Week 3. It is therefore not possible to describe the observed distribution, its change over time or the precision of an estimate for erythema.
This distinction matters: a defined outcome is not the same as a reported result. The scale offers categories from no observable redness through severe redness with edema, but without the outcome counts, the scale cannot establish what was observed in this study. The listed enrollment of 35 does not fill that gap. No numerical primary outcome should be inferred from enrollment, completion status or the study’s stated purpose.
The design is single-group and has no separate comparator. Even if outcome values were available, this design would describe observations during use of the regimen rather than isolate a comparative effect against another regimen. Changes over visits could reflect multiple influences, and the registry record does not provide a control group that could help distinguish those influences. The absence of masking, as recorded, also means the study was not masked; the record does not describe any procedures to reduce the influence of expectations on assessment.
The adverse-event figures report 0 serious events among 35 at risk and 11 other events among 35 at risk. These figures describe the registry’s adverse-event categories; they are not a substitute for the missing primary endpoint results. The record does not provide the event terms for the other events, their timing, duration, severity, relationship to the regimen or participant-level detail. Deaths are not reported in the registry record.
Other outcomes are listed, including interview-based sensations, TEWL, hydration and satisfaction. Their result values are not reported in the registry record. The record also lists 12 outcome measures and 0 analyses, but does not explain whether outcome results were collected, analyzed elsewhere or omitted from the registry entry. In the absence of reported endpoint estimates and analysis details, there is no basis for assessing statistical precision or for drawing a quantitative conclusion about tolerability.
Any sample-size illustrations associated with the posted statistical material should be read as planning exercises, not as observed power or as the original study’s design rationale. The stated assumptions concern a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. This study itself is single-group, and the registry record does not report an observed primary effect from which such planning could be interpreted. The sample-size justification is not reported in the registry record.
9. Statistical Methods Explained
What does a single-group design estimate?
In general, a single-group study describes outcomes among people who receive the same intervention. It can document what was observed during the study period, but it does not directly estimate a difference between the intervention and a concurrent comparator. In this study, all subjects used the cleanser and moisturizer regimen, and the record lists no control arm. Therefore, there is no randomized between-group contrast to interpret.
Random allocation, when used, can help make comparison groups similar on average with respect to measured and unmeasured characteristics. Here, allocation is listed as NA, and the study model is single-group. The registry’s note that this is not a randomized comparison is consistent with those design details. It would be inappropriate to describe the trial as testing whether the regimen performs better or worse than an alternative.
How should the erythema scale be understood?
In general, a severity scale converts an observed feature into ordered categories. The categories have a meaningful order, but the gaps between adjacent categories are not necessarily equal. For example, the difference in severity between one score and the next need not represent the same amount of change throughout the scale. Analyses should respect that ordinal structure unless a justified alternative is specified.
The registry defines the erythema scale from 0 to 4 and describes the assessments at day 1, day 8 and day 22. It lists the endpoint unit as participants and parameter as NUMBER. It does not report the category counts, a mean or another summary, or a prespecified method for combining repeated visits. Without those details and results, neither the endpoint distribution nor an estimated change can be reconstructed.
Why do repeated assessments matter?
In general, observations from the same person over time are related. A participant’s score at one visit may be associated with that participant’s score at another visit. An analysis that treats each visit as if it came from a different person can misrepresent uncertainty. Suitable methods for repeated observations account for within-person dependence, but the choice depends on the outcome, estimand and analysis plan.
The record names multiple assessment visits but does not report the statistical method used to handle them. It also does not say whether the Week 3 endpoint represents the final visit alone, a change from an earlier visit, or another summary. That specification is not reported in the registry record, so no particular repeated-measures analysis should be presumed.
What do confidence intervals and significance tests tell readers?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while neither interval width nor a significance test establishes that an estimate is free of bias. A p-value, when reported, measures how compatible the observed data are with a specified null model; it does not measure the probability that a treatment works or that a result is true.
The registry record does not report a primary endpoint estimate, confidence interval or p-value. Statistical significance and precision therefore cannot be evaluated for the primary outcome. The stated assumptions for sample-size illustrations are planning assumptions, not evidence that the study had a particular level of power. The original sample-size justification is not reported in the registry record.
Why can over-dispersion matter?
In general, count data are sometimes analyzed using models that assume a particular relationship between the mean and variability. Over-dispersion occurs when variability is greater than that assumption allows. If not accounted for, uncertainty may be understated. This is a general consideration for count outcomes; the record does not report an over-dispersion assessment or a count-model analysis for the primary endpoint. The primary endpoint is described as a number of participants, but its observed counts are not reported.
How should sample-size planning be read?
In general, sample-size planning asks how many participants might be needed for a future study under specified assumptions about the effect to detect, the significance level, allocation and analysis method. Such calculations are conditional illustrations, not observed study findings. They do not establish the power of a completed study after results are known.
The recorded planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. They also describe planning to detect a stated fraction of an observed effect. Those assumptions do not describe the single-group design recorded for this trial, and the primary effect is not reported in the registry record. Any planning figures must therefore be kept separate from interpretation of this study’s observed outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 12 outcome measures, including the primary erythema endpoint and secondary measures of sensations, barrier function, hydration and satisfaction. Examining multiple outcomes can raise a multiplicity issue: in general, the more statistical tests performed, the greater the chance that at least one result appears notable by chance if no adjustment or hierarchy is used. The appropriate approach depends on which outcomes were confirmatory, which were exploratory and how the analyses were specified.
The registry record does not report a multiplicity adjustment, a testing hierarchy or a statistical analysis plan. It lists 0 analyses, and outcome results are not reported in the registry record. It is not possible to determine whether analyses were conducted elsewhere, whether only selected outcomes were analyzed, or how multiplicity was addressed. None of these possibilities should be assumed.
The record also does not describe missing-data counts, reasons for missing observations, imputation, or sensitivity analyses. For a study with assessments at multiple visits, incomplete observations could affect the interpretation of change over time. In general, the impact depends on how much information is missing and why it is missing. Because those details are absent, the completeness of the outcome data cannot be assessed.
The analysis population is not reported in the registry record. Although enrollment is listed as 35 and the adverse-event figures use 35 at risk, that does not establish which participants were included in each efficacy or tolerability analysis. The record does not state whether all enrolled participants were analyzed, whether any were excluded, or how deviations from the regimen were handled. These omissions limit assessment of both the representativeness of the reported results and the robustness of any analysis.
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 |
|---|---|---|---|
| Cetaphil® DermaControl™ Regimen. | 0 | 35 | 0.0% |
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 |
|---|---|
| Cetaphil® DermaControl™ Regimen. | 11 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cetaphil® DermaControl™ Regimen. |
|---|---|---|
| Contusion | Injury, poisoning and procedural complications | 2 of 35 |
| Skin burning sensation | Skin and subcutaneous tissue disorders | 2 of 35 |
| Abdominal pain upper | Gastrointestinal disorders | 2 of 35 |
| Arthropod bite | Injury, poisoning and procedural complications | 1 of 35 |
| Sunburn | Injury, poisoning and procedural complications | 1 of 35 |
| Muscle strain | Injury, poisoning and procedural complications | 1 of 35 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 1 of 35 |
| Pityriasis alba | Skin and subcutaneous tissue disorders | 1 of 35 |
| Impetigo | Infections and infestations | 1 of 35 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 35 |
The registry’s adverse-event figures report 0 serious events among 35 at risk and 11 other events among 35 at risk for the Cetaphil® DermaControl™ regimen. These are event-category counts in the registry record, not a measure of the primary erythema endpoint. The figures should not be treated as evidence that no skin reactions occurred: the record separately reports 11 other events, while the event terms and their details are not listed.
The registry does not provide the names, timing, duration, severity or assessed relationship to the regimen for the other events. It also does not give participant-level information, so the figures should be interpreted only as recorded in the adverse-event summary. The field for deaths is not populated; deaths are not reported in the registry record, which is different from a reported count of zero.
These safety figures do not establish a comparative risk because the trial has a single group and no control arm. They also do not supply the missing numerical results for erythema or the other tolerability outcomes. They are a limited description of the adverse-event categories recorded for this study, not a complete account of all tolerability findings.
12. What the Result Does, and Does Not, Mean
This record describes a short, single-group assessment of a cleanser and moisturizer SPF 30 regimen in children aged 7–11 with acne-prone skin. The regimen was used at least once daily for 22 days, and investigator-assessed erythema was designated as the primary endpoint at Week 3. The registry also lists interview-based symptoms, barrier function, hydration and product satisfaction as secondary outcomes.
What the record does not establish is the observed primary result. The erythema scores or participant counts by score are not reported in the registry record. Results for the secondary outcomes are also not reported. Without those values, it is not possible to characterize how erythema or other measured outcomes changed, or to assess the precision of any estimate.
The single-group design does not provide a concurrent comparison. Thus, the study cannot estimate a randomized contrast with another product or with no regimen. Observations during use would not, on their own, establish that the regimen caused an outcome. The lack of masking is another design feature relevant to interpretation, particularly for assessments involving judgment or participant reports.
The adverse-event summary records 0 serious events among 35 at risk and 11 other events among 35 at risk. It does not report the terms or circumstances of those other events, and deaths are not reported in the registry record. Those limited figures should not be expanded into a broader conclusion about safety or tolerability.
Overall, the registry entry documents a tolerability-focused study and its intended measures, but does not contain the outcome detail needed for a quantitative conclusion. It does not show that the regimen works or does not work, nor does it establish a comparative treatment effect. The most defensible reading is that the design and endpoint are described, while the central numerical results and key analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the registry specifies a clinical question and a graded primary endpoint, but does not report the numerical endpoint result. A detailed outcome definition can clarify what investigators intended to measure; it cannot replace the observed data. Separating outcome specification from outcome reporting is essential when judging what a registry record supports.
The single-group structure also illustrates the difference between describing outcomes and estimating a comparative effect. Repeated assessments can describe observations over time, but without a comparator they do not provide a randomized contrast. Readers should therefore avoid translating a within-group observation into a claim about what would have happened under another regimen.
The erythema endpoint uses ordered severity categories and is assessed at several visits. This raises general statistical questions about ordinal data, repeated measurements, and the method used to define a Week 3 summary. The registry does not report how those questions were handled. That absence prevents evaluation of whether the analysis matched the outcome structure.
The listed secondary outcomes span investigator observation, subject and parent reports, skin measurements and satisfaction. Such breadth can be valuable in a tolerability study, but it also makes clear why a prespecified analysis plan and transparent reporting matter. With 12 outcome measures and no reported analyses or results, it is not possible to assess how outcomes were prioritized or how multiplicity was handled.
Finally, the safety summary is limited: it records serious and other event counts, but not the event descriptions or details needed to interpret them fully. This record therefore offers a useful example of why design information, outcome definitions, numerical results and analysis methods are all needed for a complete statistical reading.
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 most direct limitation is the absence of numerical results for the primary erythema endpoint. The registry defines the scale and assessment visits, but does not report the score distribution or another Week 3 summary. Secondary outcome values are also not reported in the registry record, so the listed measures cannot be interpreted quantitatively.
The single-group design has no concurrent comparator, and allocation is listed as NA. Masking is listed as NONE. These features limit the ability to distinguish outcomes associated with product use from changes that could occur for other reasons, and leave assessments potentially open to expectation or observer effects. The registry does not describe any methods used to address those concerns.
The record does not report the analysis plan, analysis population, missing-data handling, or the method for using the assessments at day 1, day 8 and day 22. It is therefore not possible to determine how repeated observations were summarized or how incomplete records, if any, were handled. The study’s sample-size justification is not reported in the registry record.
The adverse-event summary does not name the 11 other events or describe their severity, timing, duration or relationship to the regimen. Deaths are not reported in the registry record. The event figures cannot provide a full account of tolerability and do not substitute for the missing primary and secondary outcome results.
Finally, the registry lists 12 outcome measures and 0 analyses without explaining the status of outcome collection or analysis. This limits assessment of reporting completeness. These are limitations of the information in the registry record; they do not establish what may or may not have been reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin. — NCT01909713.
- Registry record last updated 2022-08-23; status last verified 2013-12.
- Results first posted 2014-03-24.
- 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
This completed Phase 4 study was a single-group assessment of a cleanser and moisturizer SPF 30 regimen in children aged 7–11 with acne-prone skin. Enrollment was 35. Subjects used the Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Allocation was listed as NA and masking as NONE.
The primary endpoint was investigator-assessed erythema at Week 3, with assessments described at day 1, day 8 and day 22. The registry record does not report the primary endpoint values or results for the listed secondary outcomes. It records 0 serious events among 35 at risk and 11 other events among 35 at risk; details for the other events are not reported. The analysis plan, analysis population, missing-data handling and sample-size justification are not reported in the registry record.