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

Primary Purpose

Actinic Keratoses

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PBN

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring plum-blossom needling, Photodynamic Therapy, Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Dermatology HospitalRecruiting
Xiuli WangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PBN-ALA-PDT Group

ALA-PDT Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment sessions

Number of treatment sessions required for clinical cure

Number of new Actinic Keratoses

The change in number of actinic keratoses at each follow-up will be measured as the second outcome

Adverse events

Measurement of crusting, erythema, edema, pain and et al.

Full Information

NCT ID

NCT03596619

First Posted

July 12, 2018

Last Updated

March 18, 2019

Sponsor

Shanghai Dermatology Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03596619

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 30, 2018 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Dermatology Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses

Keywords

plum-blossom needling, Photodynamic Therapy, Actinic Keratoses

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PBN-ALA-PDT Group

Arm Type

Experimental

Arm Description

Arm Title

ALA-PDT Group

Arm Type

No Intervention

Arm Description

The ALA-PDT group received ALA cream and irradiation only.

Intervention Type

Device

Intervention Name(s)

PBN

Intervention Description

Primary Outcome Measure Information:

Title

The clearance rate of Actinic Keratoses

Description

The change rate in lesion clearance of Actinic Keratoses at two weeks after the first session will be measured as the primary outcome

Time Frame

two weeks after first session

Secondary Outcome Measure Information:

Title

Treatment sessions

Description

Number of treatment sessions required for clinical cure

Time Frame

two weeks after the last session

Title

Number of new Actinic Keratoses

Description

The change in number of actinic keratoses at each follow-up will be measured as the second outcome

Time Frame

1, 3, 12 months after last session

Title

Adverse events

Description

Measurement of crusting, erythema, edema, pain and et al.

Time Frame

1, 3, 12 months after last session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peiru Wang, PhD

Phone

021-18017336579

wpeiru@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lude Zhu, MD

Phone

021-15821804557

zhulude0318@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PhD, MD

Organizational Affiliation

Shanghai Skin Disease Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Dermatology Hospital

City

Shanghai

State/Province

Jingan

ZIP/Postal Code

200443

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peiru Wang, PHD

Phone

021-18017336579

wpeiru@qq.com

First Name & Middle Initial & Last Name & Degree

Lude Zhu, MD

Phone

021-15821804557

zhulude0318@163.com

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PHD,MD

First Name & Middle Initial & Last Name & Degree

Peiru Wang, PHD

First Name & Middle Initial & Last Name & Degree

Hongwei Wang, PHD

First Name & Middle Initial & Last Name & Degree

Kun Chen, PHD, MD

First Name & Middle Initial & Last Name & Degree

Hang Li, PHD, MD

First Name & Middle Initial & Last Name & Degree

Xiaojing Kang, PHD, MD

Facility Name

Xiuli Wang

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200443

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lude Zhu

Phone

15821804557

zhulude0318@163.com

First Name & Middle Initial & Last Name & Degree

Peiru Wang

Phone

18017336579

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://www.ncbi.nlm.nih.gov/pubmed

Citations:

PubMed Identifier

25950503

Citation

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.

Results Reference

result

PubMed Identifier

27375183

Citation

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.

Results Reference

result

PubMed Identifier

22136038

Citation

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.

Results Reference

result

PubMed Identifier

6567734

Citation

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.

Results Reference

result

Learn more about this trial

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

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