Actinic Keratosis
Conditions
Keywords
Photodynamic Therapy, Conventional, Painless, Actinic Keratosis
Brief summary
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
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.
Interventions
Aminolevulinic acid photodynamic therapy
Sponsors
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator assesses photographs without prior knowledge of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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); 2. 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
1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; 2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; 3. Take phototoxic or photosensitizer within 8 weeks; 4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues; 5. Serious immunocompromised persons; 6. scar constitution; 7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; 8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clearance rate of Actinic Keratoses | six weeks after treatment | The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour | 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 |
Countries
China
Contacts
Primary ContactYunfeng Zhang, MD
Backup ContactHaiyan Zhang, MD
Outcome results
None listed