The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis

Study Overview
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Brief Summary
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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.

Official Title
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The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis: a Randomized and Multi-center Clinical Trial

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Device: PBN


Participation Criteria
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Eligibility Criteria
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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.

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBN-ALA-PDT Group<br>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). | Device: PBN<br>* 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.<br>|
| No Intervention: ALA-PDT Group<br>The ALA-PDT group received ALA cream and irradiation only. | |

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 two weeks after the first session will be measured as the primary outcome | two weeks after first session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment sessions | Number of treatment sessions required for clinical cure | two weeks after the last session | 
| Number of new Actinic Keratoses | The change in number of actinic keratoses at each follow-up will be measured as the second outcome | 1, 3, 12 months after last session | 
| Adverse events | Measurement of crusting, erythema, edema, pain and et al. | 1, 3, 12 months after last session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic Therapy, plum-blossom needling, Actinic Keratoses