Exacerbation of Erythema Following PDT in Patients With Probable Capillary Malformation-Arteriovenous Malformation Syndrome: Retrospective Analysis of Ultrasound and Clinical Characteristics.

NCT06985563 | Completed

• 1 other identifier: 2024213
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Probable Capillary Malformation-Arteriovenous Malformation Syndrome

Keywords

exacerbation of erythema following PDT; probable CM-AVM syndrome; Ultrasound; retrospective study

Outcome Measures

Primary Outcomes (1)

• 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.

  The efficacy evaluation will be conducted 3 months after the completion of the 1st HMME-PDT treatment.

Study Arms (1)

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.

Combination Product: HMME-PDT; Device: Ultrasound examinations

Interventions

HMME-PDT COMBINATION_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.

Exacerbation of erythema following PDT group

Ultrasound examinations DEVICE

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).

Exacerbation of erythema following PDT group

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Related Publications (4)

• 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.

  PMID: 32363619 BACKGROUND

• Cen 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.

  PMID: 32635943 BACKGROUND

• Valdivielso-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.

  PMID: 32124491 BACKGROUND

• Liu 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.

  PMID: 35840007 BACKGROUND

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)