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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Painless Photodynamic Therapy(P-PDT) group | Experimental | 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. |
|
| Conventional Photodynamic Therapy(C-PDT) group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic acid photodynamic therapy | Procedure | Aminolevulinic acid photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | six weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfeng Zhang, MD | Contact | 18217422425 | 18217422425 | yunfeng0519116@aliyun.com |
| Haiyan Zhang, MD | Contact | 18017336573 | zhanghaiyan10842@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Wang, PHD,MD | Shanghai Skin Disease Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunfeng Zhang | Recruiting | Shanghai | Jinan | 200443 | China |
underlie results
One year after finishing this srudy and for permanency
anyone who search pubmed
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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Evaluator assesses photographs without prior knowledge of intervention
| D017437 |
| Skin and Connective Tissue Diseases |