The Impact of Chronic Adolescent Skin Conditions on Sexual Health: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Impact of Chronic Adolescent Skin Conditions on Sexual Health (NCT06397664), a registered phase not stated study. The primary outcome is Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year.

2. Clinical Question

The study asks how chronic skin conditions relate to quality of life, sex and intimacy among young people receiving dermatology follow-up. Its stated aims include exploring sexual dysfunction and identifying factors associated with the impact of skin conditions. The registry describes an anonymous online survey and perspectives from patients aged 17 - 25 years. This is an observational question: the record does not describe an assigned treatment or a randomized comparison.

The listed secondary outcomes address confidence in pursuing romantic or intimate relationships, symptoms that impede intimacy, feeling supported while still struggling, and participants' views on clinicians reframing communication. These topics make the study relevant to experiences that may not be captured by a quality-of-life score alone. However, the registry record does not give results for those outcomes, describe their analysis, or report the instruments used to assess them.

3. Trial Design

This is a completed observational cohort study sponsored by Oxford University Hospitals NHS Trust. The registry record gives a start date of 2024-04-29 and a primary completion date of 2024-08-01. Enrollment is listed as 91. Participants were follow-up patients aged 17 - 25 years seen by dermatology departments at Oxford University Hospitals NHS Trust and were to complete an anonymous online survey about their skin condition and its effects, including on sex and intimacy.

The study title describes quantitative and qualitative methods, and the registry summary refers to gaining patient perspectives. The record does not detail the qualitative data collection or analysis, nor does it explain how the survey responses were processed. Allocation is not stated. The record explicitly cautions that this is not a randomized comparison and that arms are not like-for-like controls. Accordingly, the study design supports description of reported experiences and associations, but does not establish effects caused by a treatment or by a skin condition compared with a randomized control.

The registry lists nine outcome measures and zero analyses. It lists one observational cohort group for adverse events, with zero participants at risk and zero affected participants in the serious and other event fields, and no serious event terms. These registry entries do not provide a participant flow or outcome-specific denominators. In particular, enrollment of 91 does not establish that all enrolled participants completed the survey or contributed to the primary outcome.

The planned sample-size illustration is described as using the observed effect, two-sided significance level 0.05, equal allocation and a normal approximation. It is a planning exercise, not observed power. The effect estimate and numerical planning results are not reported in the registry record. Further details of recruitment, eligibility criteria, survey completion, and the statistical analysis plan 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.

Only the first 6 of 8 groups are shown.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The modified Teenager's Quality of Life Index (T-QOL) was analysed only for conditions with three or more participants. Although the "Other Diagnosis" arm comprised five participants in total, each individual condition within this arm had fewer than three participants, precluding meaningful arm-level reporting.

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.

Only the first 6 of 9 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Scores From the Modified Teenager's Quality of Life Index (T-QOL) to 1 Year, measured over Baseline assessment at study enrolment, collected prospectively via participant self-report questionnaires..

The primary outcome is the mean score on the modified Teenager's Quality of Life Index (T-QOL). The measure is a validated self-reported questionnaire intended to assess the impact of skin disease on adolescent quality of life. Its total score ranges from 0 to 36 and combines three subscales: Self-image, scored from 0 to 16; Physical wellbeing and future aspirations, from 0 to 8; and Psychological impact and relationships, from 0 to 12. Higher scores indicate greater impairment in quality of life, so a higher mean represents worse reported quality of life on this measure.

The recall period was modified from 1 week to the previous 12 months to capture the impact of chronic relapsing and remitting skin conditions. That change may help encompass experiences across a longer period, but it also means the measure used in the study differs in recall period from the described standard questionnaire. The registry record identifies the timeframe as a baseline assessment collected prospectively through participant self-report questionnaires. Although the outcome title refers to 1 year, the stated timeframe describes a baseline assessment; repeated assessments are not detailed in the record.

A mean provides a group-level summary of scores, while the standard error describes the precision of that estimated mean. The registry record does not report the primary outcome mean, its standard error, or a confidence interval. Therefore, the direction and magnitude of the observed scores cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical explanation: the primary outcome is continuous because it is a score on a numerical scale. A mean summarizes the average score among participants included in an analysis. The standard error describes the precision of that estimated mean; it is not the spread of individual participants' scores. A standard deviation, which describes variation among individual scores, is not listed as the reported dispersion measure for the primary outcome.

The T-QOL score is formed by summing three subscale scores. The total ranges from 0 to 36, and higher scores mean greater impairment. Because the endpoint is a mean, interpretation depends on both the score direction and who contributed data. A mean alone does not show how scores are distributed: participants can have different experiences even when the group average is the same. The registry record does not report the mean, standard error, score distribution, or outcome denominator, so those features cannot be evaluated for this study.

The registry describes the questionnaire as validated, self-reported, and modified to use a 12-month recall period rather than 1 week. General measurement consideration: a longer recall period may include a broader range of experiences, while requiring participants to remember experiences across more time. The record explains the reason for the modification, namely chronic relapsing and remitting skin conditions, but does not report a separate validation assessment of the modified recall period. The primary timeframe is described as a baseline assessment collected prospectively by questionnaire, even though the outcome title refers to 1 year. Details of any later assessment are not reported in the registry record.

General explanation of uncertainty: a standard error can be used to construct a confidence interval when the relevant assumptions and method are specified. The interval represents uncertainty around an estimated quantity; it does not describe the range of individual participant scores. No confidence interval or method for deriving one is reported for the primary outcome. Without the estimate and its uncertainty, precision cannot be judged, and a comparison cannot be quantified.

General explanation of observational comparisons: an observational cohort records participants' conditions or experiences without assigning them at random to treatment groups. Differences between diagnosis groups can be associated with the condition labels, but groups may also differ in other respects. Randomization is not described, and the registry explicitly warns that the arms are not like-for-like controls. The record does not state whether any regression, stratification, or other adjustment was used. It is therefore not possible to assess whether reported or potential group contrasts account for differences in participant characteristics.

The eligibility rule for the primary outcome is condition-specific: only conditions with three or more participants were analyzed. The record further states that the five participants classified under Other Diagnosis had individual conditions represented by fewer than three participants, so those individual conditions were not suitable for meaningful arm-level analysis. General statistical explanation: very small groups typically yield imprecise estimates, and a single participant's score can have substantial influence on a group mean. The record does not give the analyzed sample sizes or results for the included conditions, so the extent of this issue in each estimate cannot be quantified.

The registry describes a sample-size planning illustration using the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. General explanation: a planning calculation estimates how many participants might be needed under chosen assumptions to detect an effect of a specified size. Its result depends on those assumptions and is not a measure of actual study power after data collection. The described calculation uses a fraction of the observed effect, but the effect and numerical planning results are not reported in the registry record. The study is observational, and the record does not describe a randomized two-arm design; the planning assumptions should not be mistaken for evidence of such a design. No observed-power conclusion can be drawn from this information.

General explanation of over-dispersion: for count outcomes, over-dispersion means that variability exceeds what a simple count model expects, and can make standard errors too small if ignored. That concern is not directly applicable to the continuous T-QOL mean described as the primary outcome. The registry record gives no count-model methods for the secondary outcomes, so it is not possible to say whether any such methods or checks were used.

The study lists nine outcome measures but zero analyses. No analysis populations, model specifications, covariate choices, missing-data procedures, or multiplicity adjustments are reported in the registry record. Consequently, the statistical method beyond the primary outcome's mean and standard error is not described in enough detail to reproduce or appraise an analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures, including the primary T-QOL score and secondary outcomes concerning relationships, intimacy, support, and communication. It reports zero analyses. No analysis results are available to show whether these outcomes were evaluated, and no procedure for addressing multiple outcomes or multiple comparisons is reported in the registry record.

General statistical explanation: when several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase if each is assessed separately. A prespecified approach to multiplicity can help readers interpret a family of tests. The record does not report whether outcomes were ranked, whether testing was adjusted, or whether any analyses were designated exploratory. No conclusion about multiplicity control is possible.

Missing-data information is also not reported in the registry record. Enrollment is 91, but the number completing the survey, the number with a usable T-QOL score, and the number included for each condition are not given. No account of incomplete questionnaires, excluded responses, or missing individual items is stated. The analysis population and any imputation or other missing-data handling are not reported.

These omissions matter because the outcome population was limited to conditions with three or more participants. Without condition-specific denominators, it is not possible to determine how many participants contributed to each eligible group or whether missing responses affected groups differently. The registry describes a baseline assessment but does not report whether repeated measurements were collected or how they would be handled.

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

The registry record documents a study designed to gather young patients' perspectives on chronic skin conditions, quality of life, and sexual health. It specifies a modified self-report quality-of-life measure and identifies relationship and intimacy topics among the secondary outcomes. These details establish what the study set out to examine, but they are not results.

No numerical outcome findings are reported in the registry record. It is therefore not possible to state how impaired quality of life was in the analyzed participants, whether scores differed among conditions, how precise any estimate was, or whether any association with sexual health was observed. A study's completion status and enrollment count do not fill that gap. The record lists 91 enrolled participants, but does not report the number with analyzable outcome data.

General interpretation: an observational survey can describe participants' reported experiences and may identify associations within the observed sample. By itself, it cannot establish that a skin condition caused a particular sexual-health outcome, nor that a clinical service or communication approach changed outcomes. The registry does not describe a randomized intervention comparison, and its own note says the arms are not like-for-like controls.

The instrument's higher-is-worse scoring direction is useful for interpreting a future reported mean, but without the actual mean and uncertainty it gives no estimate of the sample's experience. Likewise, zero adverse events listed in the registry's single observational cohort does not establish that no adverse experiences occurred; the record reports zeros in the adverse-event fields and does not provide further ascertainment details.

The appropriate reading is therefore limited: the record describes the question, cohort, and intended measurement, while the results needed to judge the observed patterns are not reported in the registry record. Neither a positive nor a null finding can be inferred from that absence.

12. Why This Trial Matters Statistically

Sexual health and intimacy are among the topics the study explicitly sought to examine alongside quality of life in young people with chronic skin conditions. The registry summary notes that these concerns may not routinely be addressed in dermatology consultations and describes limited data on their scale and associated factors. A study focused on patient-reported perspectives can therefore address questions that may not be captured by clinical measures alone.

Statistically, the study highlights the importance of defining what a quality-of-life score measures and how it is collected. The modified T-QOL uses a 12-month recall period, rather than 1 week, to reflect chronic relapsing and remitting conditions. Its total and subscale ranges, and the direction in which scores indicate worse impairment, give an interpretable measurement framework. At the same time, the modification and reliance on self-report need to be considered when interpreting any eventual estimates.

The condition-based eligibility rule also matters. Restricting analysis to conditions represented by three or more participants acknowledges the limits of very small groups, while excluding individual conditions within the Other Diagnosis group from meaningful arm-level analysis. This creates a distinction between overall enrollment and the population represented in a condition-specific analysis. Outcome denominators and results would be needed to understand that distinction empirically.

The registry record does not report analysis findings, so the statistical importance lies in the design and measurement question rather than in a demonstrated effect. The observational design can support description and exploration, but the record does not support causal claims or establish the performance of a service or intervention.

13. 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 this study from the registry record is the absence of posted outcome estimates. Although the primary measure and its scoring are described, its mean and standard error are not reported. The record also lists zero analyses, so no estimate of the size or precision of the primary outcome can be examined.

The registry reports enrollment of 91 but not the number of participants who completed the survey, posted a usable primary score, or contributed to each condition-specific analysis. This makes it impossible to assess outcome-specific denominators or participant flow. The record does not report missing-data counts, exclusions, or methods for handling incomplete responses.

The modified T-QOL uses a recall period of the previous 12 months rather than 1 week. The registry explains this choice in relation to chronic relapsing and remitting conditions, but does not report a validation assessment for the modified recall period. The timeframe is described as a baseline assessment even though the outcome title refers to 1 year; the record does not clarify whether additional assessments occurred.

Condition-level interpretation is limited by the stated eligibility rule of three or more participants per condition. The five participants in Other Diagnosis were not represented as individual condition groups because each condition had fewer than three participants. Results for those conditions are not reported, and there is no information about the composition of the broader eligible groups.

The observational design and absence of a like-for-like control comparison limit causal interpretation. The registry does not report adjustment methods, detailed survey procedures, or qualitative analysis methods. It also does not describe how the secondary outcomes were measured or analyzed. These limitations reflect missing methodological and results information in the registry record; they do not establish that particular procedures were or were not carried out.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: The Impact of Chronic Adolescent Skin Conditions on Sexual Health — NCT06397664.
• Registry record last updated 2026-10-26; status last verified 2026-07.
• Results first posted 2026-10-26.
• 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.

17. Record Summary

The registry record describes a completed observational cohort study sponsored by Oxford University Hospitals NHS Trust, with enrollment of 91. The study start date is 2024-04-29 and the primary completion date is 2024-08-01. It concerns follow-up dermatology patients aged 17 - 25 years and uses an anonymous online survey to explore quality of life, sex, and intimacy in relation to chronic skin conditions.

The primary outcome is the mean score on a modified T-QOL, with higher scores indicating greater impairment. Its recall period was changed from 1 week to the previous 12 months. The registry lists nine outcome measures and zero analyses. Primary and secondary numerical results, outcome-specific participant counts, and detailed analysis methods are not reported in the registry record.

The study is not a randomized comparison; allocation is not stated, and the registry cautions that arms are not like-for-like controls. The record supports understanding the study's aims and measurement approach, but not a judgment about its observed findings.