Port-wine StainPhase 4NCT03125057
A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain
A Phase 4 study testing Hemoporfin PDT in people with Port-wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Port-wine Stain
- What is being tested?
- Hemoporfin PDT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2017to 10 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with clinical diagnosis of PWS；
- Age range: 7 to 14 years-old；
- Voluntarily participated and Written informed consent signed
Who cannot join
- Therapy area located outside of head and neck;
- Other skin diseases that might interfere with the efficacy evaluation;
- Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
- Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
- Scar diathesis;
- Immunocompromised conditions;
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- Electrocardiographic abnormalities or organic heart diseases;
- Coagulation disorders;
- Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN);
- Psychiatric diseases; Severe endocrinopathies;
- Previous therapy of PWS within the last 4 weeks;
- Participation in any clinical studies within the last 4 weeks;
- Be judged not suitable to participate the study by the investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
About this study
Official title: A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.
- Conditions
- Port-wine Stain
- Being tested
- Hemoporfin PDT
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoporfin PDTDrug
Photodynamic therapy is performed using hemoporfin. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| low light dose | Experimental | PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes Receives: Drug: Hemoporfin PDT |
| high light dose | Experimental | PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes Receives: Drug: Hemoporfin PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start2 Aug 2017
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-wine StainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Ma, MD, Principal investigator, Bejing Children's Hospital, Capital Medical UniversityJining Tao, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125057
- Sponsor's protocol ID
- HMME-C1610
- Status last verified
- Aug 2020
- First submitted
- 19 Apr 2017
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
- ClinicalTrials.gov ID
- NCT03125057
- Acronym / sponsor ID
- HMME-C1610
- Conditions
- Port-wine Stain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low light dose | Experimental | Drug: Hemoporfin PDTPDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes |
| high light dose | Experimental | Drug: Hemoporfin PDTPDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with clinical diagnosis of PWS；
- Age range: 7 to 14 years-old；
- Voluntarily participated and Written informed consent signed
Key exclusion criteria (13 listed)
- Therapy area located outside of head and neck;
- Other skin diseases that might interfere with the efficacy evaluation;
- Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
- Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
- Scar diathesis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoporfin PDTPhotodynamic therapy is performed using hemoporfin. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients. | Drug | high light dose, low light dose |
Primary outcome
Response rate
Time frame: week 8
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Ma, MD principal investigator
Bejing Children's Hospital, Capital Medical University
Jining Tao study director
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemoporfin PDT in people with Port-wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.