Port-Wine StainNCT04536740
Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains
A study testing PDT treatment device in people with Port-Wine Stain, run by Gang Ma.
Trial summary
Port-wine stain (PWS) is a congenital capillary malformation with an incidence of 3-5/1000 newborns and grows commensurately with the affected individual. Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- PDT treatment device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Interventional
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1-14 years who met the criteria for diagnosis of port-wine stain in The International Society for the Study of Vascular Anomalies（ISSVA);
- Patients in the untreated group had never received any treatment;
- Patients in the PDL-treated group received at least five 595 nm pulse dye laser (PDL) treatment (Vbeam laser; candela Corp., Boston, MA), The time interval between
- Photodynamic therapy and the last pulse dye laser treatment was at least 3 months;
- There were complete medical records, standard photos and test records before and after treatment;
- After fully understanding the treatment plan and risks, patients voluntarily signed the informed consent and was willing to accept clinical trials and cooperate with follow-up.
Who cannot join
- Original infection, eczema, ulcers in the lesion site; The patient has a history of seizures in the last six months or the condition is not under control;
- Hypersensitivity to porphyrins, hypersensitivity constitution;
- Scar constitution;
- A history of heavily UV exposure in the last 3 months;
- With abnormal electrocardiogram, heart disease, liver damage, pregnancy or other underlying diseases that may affect treatment;
- Patients are participating in other clinical trials.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains: a Single Center, Perspective, Paralled, Controlled Clinical Trial
Port-wine stain (PWS) is a congenital capillary malformation with an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.
Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.
In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment.
Read the detailed description
Port-wine stain (PWS) is a congenital capillary malformation characterized by ectatic capillaries and postcapillary venules located predominantly in the papillary and mid-reticular layers of the dermis. It has an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.
Pulsed dye laser (PDL) of 585 and 595 nm is considered to be the gold standard for treating PWS. Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. This ratio therefore represents a relatively large number of patients who may benefit from an alternative treatment modality.
Vascular-targeted photodynamic therapy (PDT) has been used to treat PWS since the 1990s. In 1990, Orenstein et al. used a chicken comb model to show that PDT can treat hypervascular dermal lesions while leaving the normal overlying epidermis completely intact. The use of vascular-targeted PDT for treating PWS was first described in 1991. PDT can theoretically target ectatic capillaries of all diameters and, in contrast to PDL, can induce vascular damage deeper in the dermis, with a considerably reduced risk of epidermal necrosis due to its vascular-selective characteristics. Previous studies have also demonstrated that PDT is an effective and safe means of improving the appearance of PWS.
Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.Therefore, the choice of early treatment for PWS is very important . The effect of PDL therapy on the follow-up photodynamic treatment of PWS unknown.
In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment. Our objectis to explore whether the previous PDL treatment will affect the efficacy of the follow-up PDT on PWS, so as to provide early treatment options for children with PWS.
- Conditions
- Port-Wine Stain
- Being tested
- PDT treatment device
- Keywords
- pulsed dye laser, photodynamic therapy
- 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.
PDT treatment deviceDevice
Also called light-emitting diode green-light therapeutic apparatus
All patients will be treated under general anesthesia. After carefully covering the normal skin, hematoporphyrin monomethyl ether (HMME; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai, China) was i.v. transfused at a dose of 5 mg/kg for 20 min at a constant rate. Five to 10 min after the onset of HMME transfusion, continuous irradiation at 532 nm (532-nm light-emitting diode green-light therapeutic apparatus; Wuhan Yage Optic and Electronic Technique, Wuhan, China) was applied with a power density of 80- 95 mW/cm2 for 20-30 min. Concomitant forced air cooling was applied during irradiation for epidermal protection. Post-treatment skin cooling was performed by intermittent application of ice packs over a 3-day period, to minimize pain and potential thermal damage. To prevent the effects of photosensitivity, patients were instructed to avoid exposure to strong light for at least 14 days after treatment.
| Study group | Role | What they receive |
|---|---|---|
| PDL-treated PWS | Other | PWS treated with PDL before will be treated with PDT Receives: Device: PDT treatment device |
| without treatment PWS | Experimental | PWS without treatment before will be treated with PDT Receives: Device: PDT treatment device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual evaluation
Standard digital photographs were obtained using consistent camera settings (EOS 80D; Canon, Tokyo, Japan), light conditions and patient positions. Three independent, blinded assessors qualitatively assessed color blanching
Measured: Change from Baseline Visual evaluation at 3 months after PDT treatment
Secondary outcomes (1)
Chromameter evaluation
Blanching of the PWS lesions was evaluated using a SkinColorCatch" chromameter (Delfin Technologies, Kuopio, Finland).
Measured: Change from Baseline Chromameter evaluation at 3 months after PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536740
- Sponsor's protocol ID
- SH9H-2020-T290-1
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains: a Single Center, Perspective, Paralled, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04536740
- Acronym / sponsor ID
- SH9H-2020-T290-1
- Conditions
- Port-Wine Stain
- Keywords
- pulsed dye laser, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Gang MaUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 3 Sep 2020 (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.
Port-wine stain (PWS) is a congenital capillary malformation with an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.
Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.
In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment.
Detailed description
Port-wine stain (PWS) is a congenital capillary malformation characterized by ectatic capillaries and postcapillary venules located predominantly in the papillary and mid-reticular layers of the dermis. It has an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.
Pulsed dye laser (PDL) of 585 and 595 nm is considered to be the gold standard for treating PWS. Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. This ratio therefore represents a relatively large number of patients who may benefit from an alternative treatment modality.
Vascular-targeted photodynamic therapy (PDT) has been used to treat PWS since the 1990s. In 1990, Orenstein et al. used a chicken comb model to show that PDT can treat hypervascular dermal lesions while leaving the normal overlying epidermis completely intact. The use of vascular-targeted PDT for treating PWS was first described in 1991. PDT can theoretically target ectatic capillaries of all diameters and, in contrast to PDL, can induce vascular damage deeper in the dermis, with a considerably reduced risk of epidermal necrosis due to its vascular-selective characteristics. Previous studies have also demonstrated that PDT is an effective and safe means of improving the appearance of PWS.
Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.Therefore, the choice of early treatment for PWS is very important . The effect of PDL therapy on the follow-up photodynamic treatment of PWS unknown.
In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment. Our objectis to explore whether the previous PDL treatment will affect the efficacy of the follow-up PDT on PWS, so as to provide early treatment options for children with PWS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDL-treated PWS | Other | Device: PDT treatment devicePWS treated with PDL before will be treated with PDT |
| without treatment PWS | Experimental | Device: PDT treatment devicePWS without treatment before will be treated with PDT |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged 1-14 years who met the criteria for diagnosis of port-wine stain in The International Society for the Study of Vascular Anomalies（ISSVA);
- Patients in the untreated group had never received any treatment;
- Patients in the PDL-treated group received at least five 595 nm pulse dye laser (PDL) treatment (Vbeam laser; candela Corp., Boston, MA), The time interval between
- Photodynamic therapy and the last pulse dye laser treatment was at least 3 months;
- There were complete medical records, standard photos and test records before and after treatment;
Key exclusion criteria (6 listed)
- Original infection, eczema, ulcers in the lesion site; The patient has a history of seizures in the last six months or the condition is not under control;
- Hypersensitivity to porphyrins, hypersensitivity constitution;
- Scar constitution;
- A history of heavily UV exposure in the last 3 months;
- With abnormal electrocardiogram, heart disease, liver damage, pregnancy or other underlying diseases that may affect treatment;
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 |
|---|---|---|
| PDT treatment deviceAlso: light-emitting diode green-light therapeutic apparatusAll patients will be treated under general anesthesia. After carefully covering the normal skin, hematoporphyrin monomethyl ether (HMME; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai, China) was i.v. transfused at a dose of 5 mg/kg for 20 min at a constant rate. Five to 10 min after the onset of HMME transfusion, continuous irradiation at 532 nm (532-nm light-emitting diode green-light therapeutic apparatus; Wuhan Yage Optic and Electronic Technique, Wuhan, China) was applied with a power density of 80- 95 mW/cm2 for 20-30 min. Concomitant forced air cooling was applied during irradiation for epidermal protection. Post-treatment skin cooling was performed by intermittent application of ice packs over a 3-day period, to minimize pain and potential thermal damage. To prevent the effects of photosensitivity, patients were instructed to avoid exposure to strong light for at least 14 days after treatment. | Device | PDL-treated PWS, without treatment PWS |
Primary outcome
Visual evaluation
Time frame: Change from Baseline Visual evaluation at 3 months after PDT treatment
Standard digital photographs were obtained using consistent camera settings (EOS 80D; Canon, Tokyo, Japan), light conditions and patient positions. Three independent, blinded assessors qualitatively assessed color blanching
1 secondary outcome
Chromameter evaluation
Time frame: Change from Baseline Chromameter evaluation at 3 months after PDT treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PDT treatment device in people with Port-Wine Stain, run by Gang Ma.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Ma (021-23271699 ext. 5576, docmagang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual evaluation (time frame: Change from Baseline Visual evaluation at 3 months after PDT treatment). 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 3 Sep 2020.