Surgery Versus Intra-lesional Sclerosis With Polidocanol (Aetoxisclerol) in Labial Venous Malformations in Children and Adults
NCT07933705, Phase 3, Not yet recruiting, University Hospital, Tours
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Surgery Versus Intra-lesional Sclerosis With Polidocanol (Aetoxisclerol) in Labial Venous Malformations in Children and Adults | ClinicalTrials.gov |
| NCT number | NCT07933705 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Tours | ClinicalTrials.gov |
| Conditions | Venous Malformation, Vascular Malformations | ClinicalTrials.gov |
| Interventions | Excision by surgery of the superficial venous malformation, Sclerotherapy with Aetoxisclerol 3% | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Global change | From enrollment to Month 12 post intervention | Global change will be assessed 12 months after the intervention using a Likert scale ranging from -5 to +5 (0 = no improvement or worsening, higher scores mean better outcome), based on standardized pre- and post-intervention photographs. Assessments will be performed by an independent review panel comprising three physicians (one surgeon, one dermatologist, and one interventional radiologist) and one patient with a labial VM who did not participate in the study. The evaluation will be performed blinded to treatment allocation and will encompass changes in lesion volume, scar quality, and lip symmetry. A standardized photography protocol will be used. This primary endpoint (photograph-based assessment by an independent review panel) was selected to limit bias related to the open-label nature of the study, consistent with a PROBE design (Prospective Randomized Open, Blinded Endpoint). | ClinicalTrials.gov |
| Secondary | Aesthetic impact of the venous malformation | Month 0 and Month 12 | Assessment of aesthetic burden using a 0 to 10 visual analogue scale (VAS) with higher scores mean worse outcome, measured at baseline and 12 months after the intervention. | ClinicalTrials.gov |
| Secondary | Functional impact: overall mouth function | Month 0 and Month 12 | Functional impact assessed using a 0 to 10 Visual Analogue Scale (VAS) for overall mouth function, with higher scores mean worse outcome | ClinicalTrials.gov |
| Secondary | Functional impact: lip continence | Month 0 and Month 12 | Quantification of lip continence using a self-administered drooling questionnaire (Drooling Severity and Frequency Scale \[DSFS\]), score ranging from 2 to 9 with higher scores mean worse outcome | ClinicalTrials.gov |
| Secondary | Functional impact: speech intelligibility | Month 0 and Month 12 | Speech intelligibility assessed using a self-administered questionnaire measuring speech-related intelligibility, the Intelligibility in Context Scale (ICS). Score ranging from 7 to 35, with higher scores mean better outcome | ClinicalTrials.gov |
| Secondary | Overall patient satisfaction: Likert scale | From enrollment to Month 12 | Overall patient satisfaction assessed with a Likert scale ranging from -5 to +5 (0 = no improvement and no worsening), higher scores mean better outcome | ClinicalTrials.gov |
| Secondary | Overall patient satisfaction: Goal Attainment Scale | Month 12 | Using achievement of personalized goals (maximum of three), predefined by the patient together with the investigator, assessed with the Goal Attainment Scale (GAS; scores ranging from -2 to +2, with higher scores mean better outcome). The Goal Attainment Scale (GAS) is a method for measuring treatment effectiveness by creating patient-specific outcome scales that are predefined before study participation. GAS aims to identify goals that are meaningful to the patient and related to their daily activities and individual priorities (Steinbook RM, 1977; DOI: 10.1001/archpsyc.1977.01770200061005). | ClinicalTrials.gov |
| Secondary | Number of painful days: Total number of painful days | The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post intervention visit (M12) | Total number of painful days assessed using either a patient diary or the online ePRO portal. | ClinicalTrials.gov |
| Secondary | Number of painful days: Number of painful days with a VAS pain score > 3/10 | The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post-intervention visit (M12) | Number of painful days with a VAS pain score \> 3/10 assessed using either a patient diary or the online ePRO portal. | ClinicalTrials.gov |
| Secondary | Venous Malformation volume on MRI | Month 0 and Month 12 | Venous malformation volume assessed before the intervention (within 6 months prior to treatment) and 12 months after the intervention (performed as part of routine care). Volumetric assessment will be conducted using a semi-automated thresholding method. Image analysis will be centralized and performed by an independent radiologist blinded to treatment allocation. | ClinicalTrials.gov |
| Secondary | Coagulation: D-dimer | Month 12 | D-dimer | ClinicalTrials.gov |
| Secondary | Coagulation: fibrinogen level | Month 12 | Fibrinogen level | ClinicalTrials.gov |
| Secondary | Adverse events including complications | From enrollment to Month 12 | Safety including adverse events and complications, recorded using a patient diary or the online ePRO portal | ClinicalTrials.gov |
| Secondary | Acceptability of the interventions | Month 1, Month 3 , and Month 12 | Acceptability of the interventions for the patient (or for parents in children aged \< 6 years), assessed using a 0 to 10 Visual Analogue Scale (VAS), with higher scores mean worse outcome | ClinicalTrials.gov |
| Secondary | Healthcare costs | From enrollment to Month 12 following the intervention | In each arm, patients' healthcare utilization related to the procedure and outpatient care will be measured using hospital databases and a patient diary, then valued in euros from the perspective of the healthcare system. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)