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

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.

Conditions

• Actinic Keratoses

Interventions

DEVICE

PBN

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 & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Tripler Army Medical Center

  collaborator FED

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Shanghai Dermatology Hospital

  lead OTHER

Principal Investigators

• Xiuli Wang, PhD, MD · Shanghai Skin Disease Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-30

Primary Completion

2021-12-30

Completion

2021-12-30

Countries

• China

Study Locations