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 Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae (NCT02452359), a na na study. The primary outcome is Improvement in Striae Distensae Appearance.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02452359 |
| Phase | NA |
| Condition | Striae Distensae |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 54 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Venus Concept |
| Results posted | Yes |
2. Clinical Question
The study was intended to assess whether intense pulsed light treatment with the Venus Versa device was followed by an improvement in the appearance of striae distensae. Its stated hypothesis was that, at 3 months after treatment, at least 50% of the study population would have an improvement of at least 1 point on the Global Aesthetic Improvement Scale compared with baseline.
Population
People with striae distensae were the intended study population. The registry record lists 54 participants enrolled, but further eligibility characteristics are not reported in the registry record.
Intervention
The treatment group received Venus Versa intense pulsed light energy. The study description identifies the SR580 applicator; additional treatment details are not reported in the registry record.
Comparator
This was a single-group study, not a randomized comparison. The stated endpoint compares the post-treatment appearance with baseline; a concurrent control group is not reported in the registry record.
Primary question
Did photographs taken 3 months after the last treatment show at least a 1-point improvement on the GAIS, as judged by 3 blinded reviewers? The registry record says the primary outcome was not collected, so it does not report an answer.
3. Trial Design
The registry record describes a single-group device study with 54 participants enrolled. The intervention was Venus Versa, described as a group receiving treatment with Venus Versa IPL energy. The study was not a randomized comparison: allocation is recorded as NA, and the record does not identify a separate control arm. The intended comparison was with participants’ baseline appearance, rather than with outcomes in a concurrent untreated or alternative-treatment group.
The study is listed as phase NA, with masking recorded as none. Separately, the primary outcome description says that 3 blinded reviewers were to assess photographs. That endpoint-specific reviewer blinding does not change the overall masking entry, and the record does not describe who else knew treatment assignment or how the photographic review was conducted.
The registry lists a start date of 2015-03-13 and a primary completion date of 2017-02-15. Its status is terminated. The reason for termination, the timing of termination relative to treatment and follow-up, and the number of participants who completed each study activity are not reported in the registry record. The sponsor is Venus Concept.
These design features matter when interpreting any intended before-and-after assessment. A change from baseline can describe how the measured appearance changed over time among participants with available observations, but without a concurrent comparison group it cannot separate treatment-associated change from other explanations such as natural variation, measurement variation, or changes in assessment. In this record, the primary outcome was not collected, so even that descriptive change is not available.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Each subject to receive IPL 580 nm treatment to striae distensae on either abdomen or thighs. Baseline photos taken of untreated treatment area.
Overall Study
| Stage | IPL 580 nm Treatment |
|---|---|
| STARTED | 54 |
| COMPLETED | 33 |
| NOT COMPLETED | 21 |
Reasons for not completing this period:
| Reason | IPL 580 nm Treatment |
|---|---|
| Adverse Event | 1 |
| Lost to Follow-up | 15 |
| Pregnancy | 1 |
| Withdrawal by Subject | 4 |
Analysis population for the primary outcome, as defined in the registry: The primary outcome measure is not reported as data not collected.
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 | Treatment Group |
|---|---|---|
| Participants analysed | 54 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 54 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex/Gender, Customized: Male | Participants | 1 |
| Sex/Gender, Customized: Female | Participants | 32 |
| Sex/Gender, Customized: Unknown | Participants | 21 |
| Race/Ethnicity, Customized: Hispanic | Participants | 6 |
| Race/Ethnicity, Customized: Caucasian | Participants | 25 |
| Race/Ethnicity, Customized: Other | Participants | 1 |
| Race/Ethnicity, Customized: unknown | Participants | 22 |
| Baseline photograph of treatment area | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Improvement in Striae Distensae Appearance, measured over 90 days following last IPL treatment.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was improvement in striae distensae appearance, assessed from photographs taken 3 months after the last intense pulsed light treatment. The registry also describes the timeframe as 90 days following the last treatment. Reviewers were to rate appearance using the Global Aesthetic Improvement Scale, or GAIS, with scores ranging from -3, Very Much Worse, through 0, No Change, to 3, Very Much Improved. The endpoint focused on improvement of at least 1 point compared with baseline, according to 3 blinded reviewers.
A graded scale can represent direction and degree of perceived change rather than merely recording whether any change occurred. The stated threshold makes the primary question a responder question: whether a participant’s appearance met the specified improvement criterion. The study hypothesis additionally specified that this criterion would be met in at least 50% of the study population.
In general, a photographic assessment can support consistent review of appearance when images are collected and interpreted according to a defined process. The registry record does not report details such as how reviewer ratings were combined, how disagreement was handled, or whether the scale was assessed for reliability in this study. Most importantly, the registry says the primary outcome was not collected. It therefore reports the planned measure, not observed GAIS ratings or the number of participants meeting the improvement threshold.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains a planned primary endpoint and a study hypothesis, but it does not contain primary outcome data. It explicitly states that the primary outcome measure was not reported because data were not collected. The record also lists 0 analyses. Consequently, there is no reported estimate of GAIS change, no reported count of participants meeting the improvement criterion, and no reported statistical test or confidence interval for the primary question.
The hypothesis that at least 50% of participants would achieve at least a 1-point improvement is a statement of what the study intended to evaluate. It is not an observed result. The enrollment count of 54 does not indicate how many participants completed treatment, returned for photographic follow-up, or could have been assessed, because those counts are not reported in the registry record.
The single-group, baseline-referenced design would have limited what could be concluded even if outcome data were available. In general, a before-and-after comparison can describe change among measured participants, but without a concurrent control group it cannot establish how much of that change is attributable to the intervention rather than other influences. The registry record also does not report an allocation method or an untreated comparison group.
The record reports that 3 blinded reviewers were to judge photographs. This is a feature of the intended outcome assessment, not evidence that treatment assignment was masked throughout the study. Overall masking is recorded as none. The record does not explain the image-review procedure or reviewer agreement.
The safety entries list 54 participants at risk for serious adverse events and 0 affected, and 54 at risk for other adverse events and 0 affected. These are the posted counts. They do not supply detail about event definitions, collection periods, follow-up completeness, or whether any events were not captured. A zero count in the registry should therefore be read as a reported count, not as proof that no events occurred outside the recorded ascertainment.
The study status is terminated, but the reason is not reported in the registry record. Termination alone does not explain whether or why data collection stopped, and it does not establish the cause of the missing primary outcome. Taken together, the record describes the intended study question and some safety counts, but does not provide efficacy findings or enough detail to determine why the primary endpoint was unavailable.
9. Statistical Methods Explained
The registry record does not report a statistical analysis plan for the primary endpoint. It lists 1 outcome measure and 0 analyses, and it states that primary outcome data were not collected. Thus, no trial-specific inferential method, endpoint estimate, or uncertainty interval can be described from the record. The concepts below are general explanations of how such methods are often interpreted; they are not claims about analyses conducted in this study.
What would an endpoint estimate represent?
For a responder endpoint, an estimate would ordinarily describe the proportion of assessed participants who met the stated improvement criterion. In this study, that criterion was at least a 1-point GAIS improvement from baseline, assessed from photographs 3 months after the last treatment. An estimate would need to identify its denominator, such as whether it included all enrolled participants or only those with evaluable follow-up. That analysis population and denominator are not reported in the registry record, and no responder estimate is reported.
In general, a point estimate is a concise description of the observed data, while a confidence interval expresses uncertainty around that estimate under the assumptions of the method. A confidence interval is not a guarantee that the true value lies within a particular interval, and its interpretation depends on the design, the data, and the statistical procedure. No confidence interval for the primary endpoint is reported in the registry record.
What would a significance test answer?
In general, a significance test compares data with a specified null hypothesis under an assumed statistical model. A p-value describes how unusual the observed data would be under that null hypothesis and model; it does not measure the probability that a treatment works, nor does it measure the size or practical importance of an effect. No primary endpoint test or p-value is reported in the registry record. Without observed endpoint data, readers cannot assess either the magnitude of the outcome or its statistical uncertainty.
The stated hypothesis refers to a threshold: at least 50% of the study population achieving the defined improvement. A statistical analysis addressing that hypothesis would need to specify how the threshold was evaluated, how missing observations were handled, and which participants formed the analysis population. Those details are not reported in the registry record. The stated hypothesis should not be mistaken for a prespecified analysis method or for evidence that the threshold was met.
Why does the design affect interpretation?
In general, measurements before and after an intervention can be compared within the same participants. Such a comparison can describe observed change, but it does not supply the counterfactual outcome: what would have happened to those same participants over the same period without the intervention. A concurrent control group can help address that question, subject to its own design and analysis assumptions. This study is recorded as single-group, and no concurrent comparator is reported. Even a complete before-and-after dataset would therefore have supported a more limited interpretation than a randomized controlled comparison.
The endpoint relies on photographic judgments by 3 blinded reviewers. In general, blinded assessment can reduce the influence of knowledge about treatment when ratings are made. It does not, by itself, resolve all measurement uncertainty. A statistical plan might specify how multiple ratings are combined, whether ratings are analyzed separately or jointly, and how disagreement is handled. Such procedures are not reported in the registry record.
How should planning illustrations be understood?
Planning illustrations are distinct from analyses of trial results. The stated planning assumptions describe a two-arm calculation with two-sided significance level 0.05, equal allocation, and a normal approximation, with the effect to detect set as a stated fraction of an observed effect. The assumptions also distinguish participants per arm for ordinary outcomes from total events for time-to-event calculations. These are planning conventions, not observed findings or evidence of the study’s original design.
The actual study is recorded as single-group, so a two-arm planning illustration does not describe its allocation. The record does not report the trial’s own sample-size justification. Any planning illustration should be read as an example of the sample size associated with its stated assumptions, not as the number needed to interpret the enrolled cohort, not as a reconstruction of the protocol, and not as observed power. Observed power is not a substitute for an effect estimate and its uncertainty.
Over-dispersion is a general concern when count or rate data vary more than a chosen model expects. If ignored, uncertainty estimates can be too small. The primary endpoint in this record is a threshold-based photographic assessment, and no model or dispersion estimate is reported; over-dispersion is therefore not a reported feature of this analysis. More broadly, every statistical method depends on how outcomes are measured, who is included, and how missingness is treated. Those details cannot be recovered from the stated hypothesis alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 1 outcome measure and 0 analyses. It does not report multiple primary endpoints or a set of statistical tests, but the absence of reported analyses should not be treated as evidence that a multiplicity plan was unnecessary or that no additional analyses were contemplated. A formal plan for handling multiple outcomes, time points, reviewers, or comparisons is not reported in the registry record.
The primary outcome is explicitly described as not reported because data were not collected. This is more consequential than an ordinary situation in which some participants have missing follow-up: the registry does not provide an observed endpoint result from which to evaluate the stated hypothesis. The number with missing photographs, the reasons for non-collection, and the timing of any loss to follow-up are not reported in the registry record.
In general, missing-data methods rely on assumptions about why observations are missing and how the missing outcomes relate to observed information. Different assumptions can lead to different estimates. A complete-case analysis, imputation approach, or sensitivity analysis cannot be attributed to this study because none is reported. The record also does not define an analysis population, explain whether all enrolled participants were intended to be analyzed, or distinguish participants who began treatment from those who completed follow-up.
The status is terminated, but the record does not report whether termination led to outcome non-collection or why it occurred. No reason should be inferred from the status alone. Without outcome data, a defined analysis population, and an account of missingness, the primary question remains unanswered in the registry record.
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 |
|---|---|---|---|
| IPL 580 nm Treatment | 0 | 54 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IPL 580 nm Treatment | 0 of 54 |
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 |
|---|---|
| IPL 580 nm Treatment | 0 of 54 |
The registry lists 54 participants at risk for serious adverse events and 0 participants affected. It also lists 54 at risk for other adverse events and 0 affected. The death count is 0. These entries describe the counts recorded in the registry; they are not a detailed account of event types, timing, severity beyond the serious-event classification, or duration of safety follow-up.
In general, an adverse-event count depends on how events are defined, solicited, assessed, and recorded, as well as on how long participants are followed. The registry record does not report those details, nor does it describe how complete safety ascertainment was. The listed number at risk should not be interpreted as proof that every enrolled participant received treatment or completed the same period of observation.
Zero recorded events means that none are listed as affecting participants in these entries. It does not establish that an event was impossible, nor does it establish what would have been observed under a different follow-up or reporting process. The safety counts should be read separately from the missing primary outcome: the zero event counts do not fill in the absent photographic endpoint or provide a comparison group.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a single-group study of Venus Versa intense pulsed light was registered for evaluating the appearance of striae distensae, with 54 participants enrolled. It describes a planned photographic GAIS endpoint at 3 months after the final treatment and a hypothesis concerning the proportion achieving at least a 1-point improvement. It also reports zero serious adverse events, zero other adverse events, and zero deaths in its safety entries.
It does not establish whether the appearance of striae distensae improved. The primary outcome is recorded as not collected, and no analyses are listed. The stated hypothesis is not a result; the enrollment count is not a response count; and the safety counts are not evidence about the primary appearance endpoint.
Even if the planned endpoint had been observed, the single-group design would have described change relative to baseline without a concurrent control group. In general, that design cannot distinguish a treatment-associated change from other changes that occur over time or from measurement variation. The intended use of blinded reviewers may limit some assessment bias, but it does not replace a control group or resolve unreported details of rating and analysis.
The record’s terminated status does not explain why the study ended or why outcome data were not collected. Its entry therefore supports a description of the planned question, the design, and the recorded safety counts, but not a conclusion about benefit, lack of benefit, or the reason for the missing endpoint. No clinical advice follows from these registry entries.
13. Why This Trial Matters Statistically
This study illustrates why a registered hypothesis and an observed result must be kept separate. The registry gives a concrete primary question: whether photographs at the specified follow-up show at least a 1-point GAIS improvement for the stated share of participants. Yet the record says the outcome was not collected. Without the outcome, the central statistical question cannot be answered from this record, regardless of the enrolled sample size.
It also highlights the role of design in determining what an estimate could mean. A baseline comparison in a single group can describe within-participant change if measurements exist, but it does not provide the same evidence as a concurrent control comparison. The record’s endpoint-specific blinded review is relevant to measurement, while the overall masking entry remains none. These are distinct design features and should not be collapsed into one label.
Finally, the record demonstrates that safety counts, outcome availability, and study status answer different questions. Zero recorded adverse-event counts do not supply an absent efficacy endpoint, and a terminated status does not identify why data were unavailable. Clear interpretation requires attention to which observations were actually recorded, which were planned, and which design comparisons were possible. In this case, the registry supports a careful account of the plan and limits, but not a primary outcome estimate.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting the intended primary question is that the registry record states that the outcome data were not collected. It therefore supplies no GAIS ratings, responder count, effect estimate, or uncertainty interval. The listed enrollment of 54 does not show how many participants received treatment, were photographed at follow-up, or were available for assessment.
The single-group design has no reported concurrent control arm, and allocation is recorded as NA. Consequently, even if a baseline-to-follow-up change had been reported, the design would not by itself separate change associated with treatment from other explanations. Overall masking is recorded as none. Although the outcome description calls for 3 blinded reviewers, procedures for image preparation, reviewer agreement, and combining ratings are not reported in the registry record.
The status is terminated, but the reason and its relationship to data collection are not reported. Eligibility details beyond the condition, treatment delivery details, follow-up completeness, and the statistical analysis plan are also not reported in the registry record. The record does not identify an analysis population or explain how missing outcomes would have been handled.
The safety entries provide counts but not event definitions, ascertainment procedures, or follow-up duration. These limitations constrain interpretation of both the absent primary endpoint and the recorded safety counts. They do not establish why the study ended or what its results would have been under a different design or data-collection process.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae — NCT02452359.
- Registry record last updated 2020-11-03; status last verified 2020-10.
- Results first posted 2020-11-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a terminated, single-group study of Venus Versa intense pulsed light for striae distensae, with 54 participants enrolled. It lists phase as NA and masking as none. The study dates are 2015-03-13 and 2017-02-15 for start and primary completion, respectively.
The planned primary outcome was at least a 1-point GAIS improvement from baseline, judged from photographs 3 months after the last treatment by 3 blinded reviewers. The stated hypothesis was that at least 50% of the study population would meet that threshold. The primary outcome was not collected, and 0 analyses are listed.
The safety entries report 0 serious adverse events, 0 other adverse events, and 0 deaths. The reason for termination and the reason for primary outcome non-collection are not reported in the registry record.