NCT04536740|Unknown
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Sponsor study identifier
interventional
68
0 countries
N/A
Study Start
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2020
Actual (reported)September 3, 2020
Actual (reported)October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Change from Baseline Visual evaluation at 3 months after PDT treatment
Chromameter evaluation
Change from Baseline Chromameter evaluation at 3 months after PDT treatment
PWS treated with PDL before will be treated with PDT
PWS without treatment before will be treated with PDT
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.
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First Submitted
August 22, 2020
First Posted
September 3, 2020
Study Start
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Personalized Interactive Laser Therapy of Port Wine Stain
Contact the study team to confirm eligibility.
June 30, 2022
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 3, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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