Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.

NCT07663825 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: DR2000862024-517595-38-00
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief Summary

Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome. SVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain. To limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy. However, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.

Conditions

Venous Malformation, Low Flow; Venous Malformations

Keywords

superficial venous thrombosis; superficial venous malformations; acetylsalicylic acid

Outcome Measures

Primary Outcomes (1)

• The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.

  Pain intensity will be measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (the most intense pain imaginable). The child will self-assess their pain, with a parent's help if necessary, twice a day (morning and evening). The area under the EVA-time curve is calculated using the trapezoidal method based on the available values over the duration of the episode.

  The first measurement is defined as the start of treatment following the onset of pain reported by the child. VAS data will be collected until the child has a VAS of 0 for two consecutive days, or for up to 14 days.

Secondary Outcomes (12)

• Total consumption of analgesics

  Over the 14-day period after the start of treatment

• Child's quality of life

  At baseline and 2 weeks after the start of the treatment;

• Child's quality of life

  At baseline and 2 weeks after the start of the treatment;

• Sleep quality

  Measured once a day for 14 days

• Functional impairment

  Daily over 14 days, at baseline and 2 weeks after the start of the treatment;

Other Outcomes (1)

• Tolerability: Serious and non-serious adverse events

  Through study completion, an average of 2 years

Study Arms (2)

ASA + local NSAID then placebo + local NSAIDs

OTHER

This is a cross-over design. Patients randomized in this sequence will receive ASA + local NSAIDs during their first flare-up, then placebo + local NSAIDs during their second flare-up (with a wash out period of two weeks).

Drug: AAS at anti-inflammatory doses from 3 days to 14 days.; Drug: Placebo from 3 days to 14 days.; Drug: Application of Diclofenac gel 1% twice a day

Placebo + local NSAID then AAS + local NSAIDs

OTHER

This is a cross-over design. Patients randomized in this sequence will receive placebo + local NSAIDs during their first flare-up, then AAS + local NSAIDs during their second flare-up (with a wash out period of two weeks).

Drug: AAS at anti-inflammatory doses from 3 days to 14 days.; Drug: Placebo from 3 days to 14 days.; Drug: Application of Diclofenac gel 1% twice a day

Interventions

AAS at anti-inflammatory doses from 3 days to 14 days. DRUG

AAS at anti-inflammatory doses administered orally for a minimum of 3 days and a maximum of 14 days. Orally administered AAS is combined with the application of 1% diclofenac gel (NSAID) twice a day.

ASA + local NSAID then placebo + local NSAIDs; Placebo + local NSAID then AAS + local NSAIDs

Placebo from 3 days to 14 days. DRUG

Placebo administered orally for a minimum of 3 days and a maximum of 14 days. Oral placebo is combined with the application of 1% diclofenac gel (NSAID) twice a day.

ASA + local NSAID then placebo + local NSAIDs; Placebo + local NSAID then AAS + local NSAIDs

Application of Diclofenac gel 1% twice a day DRUG

Application of 1% diclofenac gel (NSAID) twice a day.

ASA + local NSAID then placebo + local NSAIDs; Placebo + local NSAID then AAS + local NSAIDs

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6 to 17 years
• Weight ≥ 20 kg
• Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
• Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
• Written consent of the child's legal representatives or of the participant if over 18 years of age
• Affiliation of a social security scheme
• Highly effective contraception for young women of childbearing age

You may not qualify if:

• Patients with deep or syndromic venous malformation
• Patients with known G6PD deficiency
• Patients with known mastocytosis
• History of hemarthrosis
• Simultaneous participation in another biomedical study
• Constitutional or acquired haemostasis pathology
• Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs)
• Frequent bleeding (epistaxis, other) requiring management
• Basic treatment of venous malformation (mTOR inhibitor)
• Active neoplasia or infection (altered coagulation balance)
• Known allergy to acetylsalicylic acid
• Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds
• Pregnant and breastfeeding women
• Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency
• Methotrexate ≥ 20 mg/week

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (6)

Centre Hospitalier Universitaire d'Angers

Angers, France

Location

Centre Hospitalier Universitaire de Brest

Brest, France

Location

AP-HM

Marseille, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

AP-HP

Paris, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

Central Study Contacts

Sophie LEDUCQ, MD, PhD

CONTACT

+332 47 47 56 02; S.LEDUCQ@chu-tours.fr

Coralie TAILLEBUIS

CONTACT

cpcq@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cross-over design with a wash out period of two weeks.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)