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

Last updated: September 24, 2024
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Hemopfin+Green Light

Vehicle+Green Light

Vehicle+PDT

Clinical Study ID

NCT05171894
F0026-US201
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be 18 to 65 years of age inclusive, at the time of signing the informedconsent.

  2. Subject is Fitzpatrick skin type I-VI.

  3. A male subject must agree to use contraception during the Treatment Period and forat least 6 months after the last dose of study treatment and refrain from donatingsperm during this period.

  4. A female subject is eligible to participate if she is not pregnant, notbreastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow thecontraceptive guidance during the Treatment Period and for at least 30 days afterthe 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 ≥2cm.

  7. Subject is capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in the informed consent form (ICF) and inthis protocol.

  8. Subject, in the Investigator's opinion, is in good general health and free of anydisease state or physical condition that may impair the evaluation of PWB or exposethe subject to an unacceptable risk by study participation.

Exclusion

Exclusion Criteria:

  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 PWBarea.

  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 interferingtopical, 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 theInvestigator at Screening.

  8. Subject has received any therapy on the treatment region that, in the Investigator'sopinion, may affect the target PWB area.

  9. Subject is currently enrolled in an investigational drug or device study, includingclinical 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 noncompliantwith 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 majorstroke) 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 theopinion of the Investigator may worsen from receipt of study treatment or subjectparticipation.

Study Design

Total Participants: 84
Treatment Group(s): 5
Primary Treatment: Hemopfin+Green Light
Phase: 2
Study Start date:
September 21, 2024
Estimated Completion Date:
April 30, 2026

Study Description

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.

Connect with a study center

  • UCI Health Beckman Laser Institute & Medical Clinic

    Irvine, California 92697
    United States

    Site Not Available

  • Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center

    San Diego, California 92121
    United States

    Active - Recruiting

  • Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE)

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Miami Dermatology and Laser Institute

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Maryland Dermatology, Laser, Skin & Vein Institute

    Hunt Valley, Maryland 21030
    United States

    Active - Recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

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