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Efficacy and safety of a novel photosensitiser, hemoporfin in photodynamic therapy for port-wine stain: a randomized, multicentre, double-blind, placebo-controlled, parallel group phase IIb study

Efficacy and safety of a novel photosensitiser, hemoporfin in photodynamic therapy for port-wine stain: a randomized, multicentre, double-blind, placebo-controlled, parallel group phase IIb study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000236
Enrollment
Unknown
Registered
2008-12-15
Start date
2006-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

port-wine stain

Interventions

20 minutes group:madication with laser 20 minutes
30 minutes group:madication with laser 30 minutes

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients were eligible for study enrolment if they were aged between 16 and 65 years with clinically diagnosed port-wine stain. The therapy area should receive no isotope treatment previously, neither systemic treatment for port-wine stain during the past 4 weeks, nor topical treatment during the past 2 weeks. All patients were given written informed consent before any study-related tests were done. If the patient is younger than 18 years, the guardian's written informed consent was also obtained. Patients were required to have adequate haematological, renal, and hepatic function.

Exclusion criteria

Exclusion criteria: Other vascular malformation, vessel related syndromes or other skin diseases that may interfere with the study evaluation; known to be allergic to porphyrins or its analogues; patients with photosensitivity or porphyria; allergic constitution or scar diathesis; immunocompromised patients; patients with electrocardiographic abnormality or known organic heart disease, coagulation disorders, psychiatric disease or severe endocrinopathy; taken known photosensitizer during the past 3 month; pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Third party assessment;

Secondary

MeasureTime frame
Patients' subjective assessment;investigators' subjective assessment;

Countries

China

Contacts

Public ContactZhu Xue-jun
zhuxj@public.bta.net.cn+86 010 66551216

Outcome results

None listed

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