Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

Official Title

A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects with Port-wine Birthmarks Treated with Hemoporfin Photodynamic Therapy

Details

This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) will receive Hemoporfin PDT or vehicle PDT in cycles at fixed drug dose (5 mg/kg) and different light fluences. This study will be conducted in two sequential stages, each contains the same schedule, which includes Screening Period, Treatment Period apart; subsequent treatment is based on efficacy evaluation, and End of Study.

Keywords

Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus, Hemoporfin, Photodynamic therapy, Capillary Hemangioma, Hemopfin+Green Light, Vehicle+Green Light, Hemoporfin+A J/cm2 Green Light, Hemoporfin+B J/cm2 Green Light, Hemoporfin+C J/cm2 Green Light

Eligibility

You can join if…

Open to people ages 18-65

  1. Subject must be 18 to 65 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 treatment and refrain from donating sperm during this period.
  4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after the last dose of study treatment.

  5. The subject has a clinical diagnosis of PWB located on the face and/or neck.
  6. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm.
  7. Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  8. Subject, in the Investigator's opinion, is in good general health and free of any disease state or physical condition that may impair the evaluation of PWB or expose the subject to an unacceptable risk by study participation.

You CAN'T join if...

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has plaque/nodular changes and severe hypertrophy within the target PWB area.
  3. Subject has Sturge-Weber syndrome or PWB involving ophthalmic nerves.
  4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.
  5. Subject is immunosuppressed related to medication use and/or disease.
  6. Subject has clinically significant ECG abnormalities at Screening
  7. Subject has clinically significant laboratory abnormalities as assessed by the Investigator at Screening.
  8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.
  9. Subject is currently enrolled in an investigational drug or device study, including clinical studies in dermatology.
  10. Subject has used an investigational drug or investigational device treatment within 30 days prior to C1D1.
  11. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity).
  12. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study.
  13. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation.

Locations

  • UCI Health Beckman Laser Institute & Medical Clinic not yet accepting patients
    Irvine California 92697 United States
  • Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center accepting new patients
    San Diego California 92121 United States
  • Miami Dermatology and Laser Institute accepting new patients
    Miami Florida 33173 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ID
NCT05171894
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated