An interventional study of Aminolevulinic acid photodynamic therapy in Actinic Keratosis, sponsored by Shanghai Dermatology Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Shanghai Dermatology Hospital · Not applicable, Interventional, and Treatment
This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Shanghai Dermatology Hospital is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 288 J/cm2) after applying 5% 5-aminolevulinic acid#ALA#cream for 30min. A repeat treatment was administered once every two weeks for 3 times.
Procedure: Aminolevulinic acid photodynamic therapy
The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.
Procedure: Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy
The clearance rate of Actinic Keratoses
The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome
Time frame: six weeks after treatment
Pain assessment
The pain will be assessed using Vissual Analogue Scale(VAS) with a score range of 0-10.The higher the score,the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment
Time frame: Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour
Plan to share: Yes — underlie results
Supporting information: Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Dermatology Hospital