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

September 7, 2023 updated by: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose (Fluence) in Subjects With Port-wine Birthmark of the Face and/or Neck Treated With Hemoporfin + Green Light Photodynamic Therapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemoporfin+A J/cm2 PDT
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Hemopfin+PDT
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Fumeida with green light photodynamic therapy
Experimental: Hemoporfin+B J/cm2PDT
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Hemopfin+PDT
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Fumeida with green light photodynamic therapy
Experimental: Hemoporfin+C J/cm2 PDT
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Hemopfin+PDT
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Fumeida with green light photodynamic therapy
Placebo Comparator: Placebo+A J/cm2 PDT
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Vehicle+PDT
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline with green light photodynamic therapy
Placebo Comparator: Placebo+B J/cm2PDT
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Vehicle+PDT
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline with green light photodynamic therapy
Placebo Comparator: Placebo+C J/cm2 PDT
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Drug: Vehicle+PDT
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline with green light photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage One：Incidence of any local and systemic adverse events.
Time Frame: From baseline until end of study, up to approximately 44 weeks
To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB)
From baseline until end of study, up to approximately 44 weeks
Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction.
Time Frame: From baseline until end of study, up to approximately 44 weeks
To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT with vehicle PDT in subjects with PWB of face and/or neck.
From baseline until end of study, up to approximately 44 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage One：Change from Baseline in overall PWB-IGA severity score and other scales.
Time Frame: From baseline until end of study, up to approximately 44 weeks
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.
From baseline until end of study, up to approximately 44 weeks
Stage Two: Change from Baseline in overall PWB-IGA severity score and other scales.
Time Frame: From baseline until end of study, up to approximately 44 weeks
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.
From baseline until end of study, up to approximately 44 weeks
Stage Two: Incidence of any local and systemic adverse events.
Time Frame: From baseline until end of study, up to approximately 44 weeks
To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB)
From baseline until end of study, up to approximately 44 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage One：Maximum observed plasma concentration (Cmax) of Hemoporfin
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
To check what time will it take to reach the maximum contraction of Hemoporfin
On the first day of the Cycle 1 (each cycle is 56 days)
Stage One：Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Hemoporfin
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
To check the drug profile for absorption, distribution, metabolism and excretion for Hemoporfin
On the first day of the Cycle 1 (each cycle is 56 days)
Stage One：Terminal elimination half-life (t1/2) of Hemoporfin
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
To check how much time Hemoporfin will take to eliminate half of it's concentration from participants.
On the first day of the Cycle 1 (each cycle is 56 days)
Stage One：Time to Cmax (Tmax) of Hemoporfin
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
To check what will be the maximum concentration participants will obtained of Hemoporfin
On the first day of the Cycle 1 (each cycle is 56 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F0026-US201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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