A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT

Recruiting Phase 2 Interventional Study
Port-wine Birthmarks Port-Wine Stain Nevus Flammeus
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
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About This Trial

This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 75 years old with PWB will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent. 2. Subject is Fitzpatrick skin type I-VI. 3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatme…
Contacts

Xuejing Cheng

00-86-021-58953355

xjcheng@fd-zj.com

CONTACT