A single-center, prospective, self-controlled study of pulsed dye laser and photodynamic therapy in the treatment of port-wine stains

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049914

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

Photodynamic therapy group :Photodynamic therapy

pulsed dye laser group:pulsed dye laser

Eligibility

Sex/Gender

All

Age

2 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 2 years old; 2. The diagnosis of port-wine stain is clear, and the lesions are located on the head, face and neck, without thickening, and the area is more than 5 cm2; 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 any treatment for head, face and neck erythema before; 5. 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. There is a 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 underlying diseases that may affect the treatment; 7. Patients who are participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Clinical efficiency;	—

Secondary

Measure	Time frame
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