Probable Capillary Malformation-Arteriovenous Malformation SyndromeNCT06985563
Exacerbation of Erythema Following PDT in Patients With Probable Capillary Malformation-Arteriovenous Malformation Syndrome: Retrospective Analysis of Ultrasound and Clinical Characteristics.
An observational study of Probable Capillary Malformation-Arteriovenous Malformation Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
This study aims to reduce the misdiagnosis rate of PWSs and improve the diagnosis of CM-AVM using ultrasound. Furthermore, we seek to provide more evidence-based recommendations for the treatment of patients with probable CM-AVM syndrome, particularly those presenting with erythema. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Probable Capillary Malformation-Arteriovenous Malformation Syndrome
- What is being tested?
- HMME-PDT and Ultrasound examinations
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited between 2017 and 2023 at the Department of Dermatology, Second Affiliated Hospital of Xi'an Jiaotong University.
Who may be able to join
- Patients who were greater than or equal to 1 year old at the time of their first HMME-PDT treatment.
- Patients who experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment.
- Patients who have undergone one or more HMME-PDT treatments. ④ Patients with complete basic information and treatment-related information.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
About this study
This study aims to reduce the misdiagnosis rate of PWSs and improve the diagnosis of CM-AVM using ultrasound. Furthermore, we seek to provide more evidence-based recommendations for the treatment of patients with probable CM-AVM syndrome, particularly those presenting with erythema.
Read the detailed description
Background: Exacerbation of erythema following photodynamic therapy (PDT) in patients with probable capillary malformation-arteriovenous malformation (CM-AVM) syndrome, may be attributed to misdiagnosis as port-wine stains (PWSs).
Objective: To identify the ultrasound features of patients with exacerbation of erythema following PDT for a definite diagnosis.
Methods: A retrospective single-center study was conducted on PWS patients with exacerbation of erythema following PDT. The clinical and ultrasonic features were reviewed and analysed. One low-frequency and two high-frequency ultrasound (HFUS) devices were used to examine the lesions and the contralateral normal skin.
Results: The clinical characteristics of 16 patients were consistent with those of high-flow vascular stains (HFVS). Ultrasound findings revealed skin and hypodermis thickening, increased blood flow signals with an arteriovenous malformation (AVM) waveform and deeper, larger blood vessels in the dermis and hypodermis of pink macules (PMs) compared to normal skin. In the absence of genetic diagnosis, PWS patients with exacerbation of erythema following PDT were diagnosed as having probable CM-AVM syndrome.
Limitations: Retrospective single-center design and small sample size. Conclusion: Patients with PWSs are advised to undergo low-frequency ultrasound examinations to avoid misdiagnosis. HFUS can serve as a complementary method to promptly identify underlying AVMs beneath the PMs. We do not recommend PDT treatment for patients with probable CM-AVM syndrome.
- Being tested
- HMME-PDT, Ultrasound examinations
- Keywords
- exacerbation of erythema following PDT, probable CM-AVM syndrome, Ultrasound, retrospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMME-PDTCombination product
Prior to treatment, patients or their guardians provided written informed consent. Then patients were then prepared for the procedure by fully exposing the treatment area and shielding the surrounding normal skin with a black cloth. Hemoporfin (Shanghai Fudan-Zhangjiang Bio-Pharmaceutical) was administrated intravenously at a dosage of 5.0 mg/kg. Subsequently, patients underwent light radiation at 532 nm (Wuhan Yage Optic and Electronic Technique, Wuhan, China) for 18 to 25 minutes, with a power density randing form 75 to 110 mW/cm2.
Ultrasound examinationsDevice
Ultrasound examinations were performed using three types of devices: a Paragon XHD equipped with a L38-22 probe operating at a frequency of 20-30 MHz (Kolo Medical Co., Ltd, Suzhou, China), a DUB Skin Scanner with a 22 MHz probe (Taberna Pro Medicum, German), or a Mindray Resona 7 featuring an L14-5WU linear probe set to a frequency range of 11-12 MHz frequency (Mindray Bio-Medical Electronics Co., Ltd, Shenzhen, China).
| Study group | Role | What they receive |
|---|---|---|
| Exacerbation of erythema following PDT group | Patients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited. Receives: Combination Product: HMME-PDT; Device: Ultrasound examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound characteristics
After cleaning and disinfecting the mesured area, the probe, coated with 1-2 millimeters of coupling agent, was positioned vertically on the skin surface. Measurements of skin thickness, density, vessel diameter, and depth were obtained for both the lesions and the contralateral normal skin. The color Doppler (CD) mode of high-frequency ultrasound was employed to assess local blood perfusion in both lesions and normal skin, while the pulsed-wave (PW) Doppler mode was used to detect the blood flow spectrum. The average of three measurements at the same site was calculated.
Measured: The efficacy evaluation will be conducted 3 months after the completion of the 1st HMME-PDT treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Probable Capillary Malformation-Arteriovenous Malformation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
- Investigators
- Weihui Zeng, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985563
- Sponsor's protocol ID
- 2024213
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez Bandera AI, Feito Rodriguez M, Chiloeches Fernandez C, Stewart N, Valdivielso-Ramos M. Role of colour-Doppler high-frequency ultrasonography in capillary malformation-arteriovenous malformation syndrome: a case series. Australas J Dermatol. 2020 Nov;61(4):349-352. doi: 10.1111/ajd.13311. Epub 2020 May 3.
PubMed 32363619Cen Q, Sun Y, Zeng X, Liu Y, Liu F, Chen H, Lin X, Cai R. Unilateral and segmental distribution of facial erythema: is it a real port-wine stain? Hereditas. 2020 Jul 7;157(1):27. doi: 10.1186/s41065-020-00143-z.
PubMed 32635943Valdivielso-Ramos M, Torrelo A, Martin-Santiago A, Hernandez-Nunez A, Azana JM, Campos M, Berenguer B, Garnacho G, Moreno R, Colmenero I. Histopathological hallmarks of cutaneous lesions of capillary malformation-arteriovenous malformation syndrome. J Eur Acad Dermatol Venereol. 2020 Oct;34(10):2428-2435. doi: 10.1111/jdv.16326. Epub 2020 May 19.
PubMed 32124491Liu J, Zhou J, Hu D, Cui L, Li Y, Ye D, Wu T, Mi B, Geng S, Zeng W. Retrospective analysis of Hemoporfin-mediated photodynamic therapy in the treatment of naive port-wine stains. Photodiagnosis Photodyn Ther. 2022 Sep;39:103003. doi: 10.1016/j.pdpdt.2022.103003. Epub 2022 Jul 13.
PubMed 35840007
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation of Erythema Following PDT in Patients With Probable Capillary Malformation-Arteriovenous Malformation Syndrome: Retrospective Analysis of Ultrasound and Clinical Characteristics.
- ClinicalTrials.gov ID
- NCT06985563
- Acronym / sponsor ID
- 2024213
- Keywords
- exacerbation of erythema following PDT, probable CM-AVM syndrome, Ultrasound, retrospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to reduce the misdiagnosis rate of PWSs and improve the diagnosis of CM-AVM using ultrasound. Furthermore, we seek to provide more evidence-based recommendations for the treatment of patients with probable CM-AVM syndrome, particularly those presenting with erythema.
Detailed description
Background: Exacerbation of erythema following photodynamic therapy (PDT) in patients with probable capillary malformation-arteriovenous malformation (CM-AVM) syndrome, may be attributed to misdiagnosis as port-wine stains (PWSs).
Objective: To identify the ultrasound features of patients with exacerbation of erythema following PDT for a definite diagnosis.
Methods: A retrospective single-center study was conducted on PWS patients with exacerbation of erythema following PDT. The clinical and ultrasonic features were reviewed and analysed. One low-frequency and two high-frequency ultrasound (HFUS) devices were used to examine the lesions and the contralateral normal skin.
Results: The clinical characteristics of 16 patients were consistent with those of high-flow vascular stains (HFVS). Ultrasound findings revealed skin and hypodermis thickening, increased blood flow signals with an arteriovenous malformation (AVM) waveform and deeper, larger blood vessels in the dermis and hypodermis of pink macules (PMs) compared to normal skin. In the absence of genetic diagnosis, PWS patients with exacerbation of erythema following PDT were diagnosed as having probable CM-AVM syndrome.
Limitations: Retrospective single-center design and small sample size. Conclusion: Patients with PWSs are advised to undergo low-frequency ultrasound examinations to avoid misdiagnosis. HFUS can serve as a complementary method to promptly identify underlying AVMs beneath the PMs. We do not recommend PDT treatment for patients with probable CM-AVM syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exacerbation of erythema following PDT group | – | Combination Product: HMME-PDT, Device: Ultrasound examinationsPatients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients experiencing exacerbation of clinical symptoms, such as darker coloration than before treatment, following at least one Hemoporfin-PDT session were recruited between 2017 and 2023 at the Department of Dermatology, Second Affiliated Hospital of Xi'an Jiaotong University.
Key inclusion criteria (3 listed)
- Patients who were greater than or equal to 1 year old at the time of their first HMME-PDT treatment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMME-PDTPrior to treatment, patients or their guardians provided written informed consent. Then patients were then prepared for the procedure by fully exposing the treatment area and shielding the surrounding normal skin with a black cloth. Hemoporfin (Shanghai Fudan-Zhangjiang Bio-Pharmaceutical) was administrated intravenously at a dosage of 5.0 mg/kg. Subsequently, patients underwent light radiation at 532 nm (Wuhan Yage Optic and Electronic Technique, Wuhan, China) for 18 to 25 minutes, with a power density randing form 75 to 110 mW/cm2. | Combination product | Exacerbation of erythema following PDT group |
| Ultrasound examinationsUltrasound examinations were performed using three types of devices: a Paragon XHD equipped with a L38-22 probe operating at a frequency of 20-30 MHz (Kolo Medical Co., Ltd, Suzhou, China), a DUB Skin Scanner with a 22 MHz probe (Taberna Pro Medicum, German), or a Mindray Resona 7 featuring an L14-5WU linear probe set to a frequency range of 11-12 MHz frequency (Mindray Bio-Medical Electronics Co., Ltd, Shenzhen, China). | Device | Exacerbation of erythema following PDT group |
Primary outcome
ultrasound characteristics
Time frame: The efficacy evaluation will be conducted 3 months after the completion of the 1st HMME-PDT treatment.
After cleaning and disinfecting the mesured area, the probe, coated with 1-2 millimeters of coupling agent, was positioned vertically on the skin surface. Measurements of skin thickness, density, vessel diameter, and depth were obtained for both the lesions and the contralateral normal skin. The color Doppler (CD) mode of high-frequency ultrasound was employed to assess local blood perfusion in both lesions and normal skin, while the pulsed-wave (PW) Doppler mode was used to detect the blood flow spectrum. The average of three measurements at the same site was calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Results publication: PubMed 32363619Rodriguez Bandera AI, Feito Rodriguez M, Chiloeches Fernandez C, Stewart N, Valdivielso-Ramos M. Role of colour-Doppler high-frequency ultrasonography in capillary malformation-arteriovenous malformation syndrome: a case series. Australas J Dermatol. 2020 Nov;61(4):349-352. doi: 10.1111/ajd.13311. Epub 2020 May 3.
- Results publication: PubMed 32635943Cen Q, Sun Y, Zeng X, Liu Y, Liu F, Chen H, Lin X, Cai R. Unilateral and segmental distribution of facial erythema: is it a real port-wine stain? Hereditas. 2020 Jul 7;157(1):27. doi: 10.1186/s41065-020-00143-z.
- Results publication: PubMed 32124491Valdivielso-Ramos M, Torrelo A, Martin-Santiago A, Hernandez-Nunez A, Azana JM, Campos M, Berenguer B, Garnacho G, Moreno R, Colmenero I. Histopathological hallmarks of cutaneous lesions of capillary malformation-arteriovenous malformation syndrome. J Eur Acad Dermatol Venereol. 2020 Oct;34(10):2428-2435. doi: 10.1111/jdv.16326. Epub 2020 May 19.
- Results publication: PubMed 35840007Liu J, Zhou J, Hu D, Cui L, Li Y, Ye D, Wu T, Mi B, Geng S, Zeng W. Retrospective analysis of Hemoporfin-mediated photodynamic therapy in the treatment of naive port-wine stains. Photodiagnosis Photodyn Ther. 2022 Sep;39:103003. doi: 10.1016/j.pdpdt.2022.103003. Epub 2022 Jul 13.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weihui Zeng study chair
Second Affiliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Probable Capillary Malformation-Arteriovenous Malformation Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound characteristics (time frame: The efficacy evaluation will be conducted 3 months after the completion of the 1st HMME-PDT treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985563, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.