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

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

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.

Study Overview

• Status: Unknown
• Conditions: Actinic Keratoses
• Intervention / Treatment: Device: PBN

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jingan
    • Shanghai, Jingan, China, 200443
      • Recruiting
      • Shanghai Dermatology Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Recruiting
      • Xiuli Wang
      • Contact: Lude Zhu; Phone Number: 15821804557; Email: zhulude0318@163.com
      • Contact: Peiru Wang; Phone Number: 18017336579

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBN-ALA-PDT Group; 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; 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.
No Intervention: ALA-PDT Group; The ALA-PDT group received ALA cream and irradiation only.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Dermatology Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital of Central South University; Peking University People's Hospital; Chinese PLA General Hospital; Henan Provincial People's Hospital; Central South University; Second Affiliated Hospital of Xi'an Jiaotong University; Wuhan No.1 Hospital; Tripler Army Medical Center

Publications and helpful links

General Publications

• Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.
• Chen J, Zhang Y, Wang P, Wang B, Zhang G, Wang X. Plum-blossom needling promoted PpIX fluorescence intensity from 5-aminolevulinic acid in porcine skin model and patients with actnic keratosis. Photodiagnosis Photodyn Ther. 2016 Sep;15:182-90. doi: 10.1016/j.pdpdt.2016.06.012. Epub 2016 Jun 30.
• Jia XH, Liu LN. [Plum blossom needling for 74 cases of scapulohumeral periarthritis]. Zhongguo Zhen Jiu. 2011 Nov;31(11):1040. No abstract available. Chinese.
• Yao ZH, Yao XL, Wan SQ. Observation on 52 cases of paralysis of common peroneal nerve treated by acupuncture and plum-blossom needling. J Tradit Chin Med. 1984 Jun;4(2):97-100. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Photodynamic Therapy; Actinic Keratoses; plum-blossom needling
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: 2018-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: underlie results
• IPD Sharing Time Frame: One year after finishing this study and for permanency
• IPD Sharing Access Criteria: anyone who search pubmed
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No