Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains
Primary Purpose
Port-Wine Stain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDT treatment device
Sponsored by
About this trial
This is an interventional treatment trial for Port-Wine Stain focused on measuring pulsed dye laser, photodynamic therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
PDL-treated PWS
without treatment PWS
Arm Description
PWS treated with PDL before will be treated with PDT
PWS without treatment before will be treated with PDT
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Chromameter evaluation
Blanching of the PWS lesions was evaluated using a SkinColorCatch" chromameter (Delfin Technologies, Kuopio, Finland).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04536740
Brief Title
Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains
Official Title
Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains: a Single Center, Perspective, Paralled, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gang Ma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
Keywords
pulsed dye laser, photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PDL-treated PWS
Arm Type
Other
Arm Description
PWS treated with PDL before will be treated with PDT
Arm Title
without treatment PWS
Arm Type
Experimental
Arm Description
PWS without treatment before will be treated with PDT
Intervention Type
Device
Intervention Name(s)
PDT treatment device
Other Intervention Name(s)
light-emitting diode green-light therapeutic apparatus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual evaluation
Description
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
Time Frame
Change from Baseline Visual evaluation at 3 months after PDT treatment
Secondary Outcome Measure Information:
Title
Chromameter evaluation
Description
Blanching of the PWS lesions was evaluated using a SkinColorCatch" chromameter (Delfin Technologies, Kuopio, Finland).
Time Frame
Change from Baseline Chromameter evaluation at 3 months after PDT treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Ma
Phone
021-23271699
Ext
5576
Email
docmagang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cen
Phone
021-23271699
Ext
5576
Email
cenqingqing1995@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains
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