Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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#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.

Official Title
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Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Procedure: Aminolevulinic acid photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged > 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study); All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions. Exclusion Criteria: Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; Take phototoxic or photosensitizer within 8 weeks; Clinical and / or pathological prove that the tumor has invaded other organs or tissues; Serious immunocompromised persons; scar constitution; Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Painless Photodynamic Therapy(P-PDT) group<br>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<br>* Aminolevulinic acid photodynamic therapy<br>|
| Active Comparator: Conventional Photodynamic Therapy(C-PDT) group<br>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<br>* Aminolevulinic acid photodynamic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic Therapy, Conventional, Painless, Actinic Keratosis