Actinic Keratoses
Conditions
Keywords
Photodynamic Therapy, Actinic Keratoses
Brief summary
Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However, in the past years, AKs have been described as a field disease and not limited to single clinically apparent lesions. Treatment should therefore target an area of field change which may treat the subclinical AKs and reduce the risk of development of further AKs, second tumours, and local recurrence. Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT, in patients with clinical signs of field cancerization. Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on one group and for a lesion area (Vehicle control cream was applied to the non-lesion area) was on the other group. During the next 5-year period of follow up, patients were clinically evaluated for new AKs.
Interventions
DRUGALA
In all face treatment group, a 1-mm thick layer of 10% ALA was applied to the all face; In AK lesion treatment group, a 1-mm thick layer of 10% ALA was applied to the lesion and to 5 mm of surrounding healthy tissue. And Vehicle control cream was applied to the non-lesion area.
Sponsors
Huadong Hospital
Peking University First Hospital
First Affiliated Hospital of Kunming Medical University
General Hospital of Ningxia Medical University
Chinese Academy of Medical Sciences
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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 |
|---|---|---|
| Number of new Actinic Keratoses | 1, 3, 6, 9, 12, 18, 24, 30, 36 months after treatment | The change in number of actinic keratoses at each follow-up will be measured as the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The clearance rate of Actinic Keratoses | 1 month after treatment | The change rate in lesion clearance of Actinic Keratoses at one month after treatment will be measured as the second outcome |
Countries
China
Contacts
Primary ContactPeiru Wang, PHD
Backup ContactLude Zhu, MD
Outcome results
None listed