Actinic Keratoses
Conditions
Keywords
plum-blossom needling, Photodynamic Therapy, Actinic Keratoses
Brief summary
Background Limited in the depth of absorption and penetration of photosensitizers, ALA-PDT treatment is not strong enough for thickening significantly AK lesions. Pre-study has proved that plum-blossom needling facilitates delivery of topical ALA into the dermis. It could help ALA to diffuse a little more broadly in superficial dermis and obtain similar clinical effect with a much lower cost. Objective We sought to investigate whether plum-blossom needling (PBN) would enhance the efficacy of ALA-PDT for AKs. Methods Two hundred and fifty patients, previously diagnosed as having AKs of the face and scalp, were randomized distribution into two groups. The PBN-ALA-PDT group underwent vertical skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode (LED) irradiation (mean 633 nm, with a standard deviation \[SD\] of 10 nm; 100-200 J/cm2). The ALA-PDT group received ALA cream and irradiation only. During the next 1 year period of follow up, patients were clinically evaluated for new AKs.
Interventions
DEVICEPBN
The PBN-ALA-PDT group underwent vertical skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode (LED) irradiation (mean 633 nm, with a standard deviation \[SD\] of 10 nm; 100-200 J/cm2). The ALA-PDT group received ALA cream and irradiation only.
Sponsors
Peking University People's Hospital
Xiangya Hospital of Central South University
Central South University
Wuhan No.1 Hospital
The First Affiliated Hospital with Nanjing Medical University
Tripler Army Medical Center
Second Affiliated Hospital of Xi'an Jiaotong University
Chinese PLA General Hospital
Henan Provincial People's Hospital
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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 |
|---|---|---|
| The clearance rate of Actinic Keratoses | two weeks after first session | The change rate in lesion clearance of Actinic Keratoses at two weeks after the first session will be measured as the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment sessions | two weeks after the last session | Number of treatment sessions required for clinical cure |
| Number of new Actinic Keratoses | 1, 3, 12 months after last session | The change in number of actinic keratoses at each follow-up will be measured as the second outcome |
| Adverse events | 1, 3, 12 months after last session | Measurement of crusting, erythema, edema, pain and et al. |
Countries
China
Contacts
Primary ContactPeiru Wang, PhD
Backup ContactLude Zhu, MD
Outcome results
None listed