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A prospective study based on pathological biopsy to predict the efficacy of photodynamic therapy for port-wine stains

A prospective study based on pathological biopsy to predict the efficacy of photodynamic therapy for port-wine stains

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049898
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

port-wine stains

Interventions

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 1 year old; 2. The diagnosis of port-wine stain is clear; 3. Simple PWS and related syndromes including SW syndrome (Sturge-Weber syndrome, SWS), phakomatosis pigmentovascularis (PPV), etc. can be included, requiring erythema and syndrome Other lesions are relatively isolated, that is, there are no other related skin pathological changes in the erythema, such as dermal melanocytosis, etc.; 4. Never received photodynamic therapy in the erythema area before; 5. The time interval between photodynamic therapy and the last pulsed dye laser treatment is at least 3 months; 6. After fully understanding the treatment plan and risks, the person or the guardian voluntarily signs the informed consent, is willing to accept the clinical trial, and cooperates with the follow-up.

Exclusion criteria

Exclusion criteria: 1. The original infection, eczema, ulcer and other lesions at the lesion site that may affect the therapeutic effect, and those with other pigmented diseases such as nevus of Ota; 2. The patient has a history of epilepsy in the past six months or the condition is not controlled; 3. Allergic to porphyrin and analogs, allergic constitution; 4. Scar constitution; 5. History of sun exposure in the past 3 months; 6. The patient has abnormal electrocardiogram, structural heart disease, abnormal liver function, women who are pregnant or planning to conceive, and other potential diseases that may affect the treatment; 7. Patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Clinical efficiency;pathologic features;Erythema blanching rate;

Countries

China

Contacts

Public ContactZhang Yuyan

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine

506553188@qq.com+86 18721979677

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026