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

ClinicalTrials.gov ID

NCT03596619

Lead Sponsor

Shanghai Dermatology HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

250Estimated

Last Update Posted

Mar 19, 2019Actual

Start Date

Aug 30, 2018Actual

Primary Completion Date

Dec 30, 2021Estimated

Completion Date

Dec 30, 2021Estimated

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

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.

• Actinic Keratoses

• PBN

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Single Group Assignment

Masking

Single

Lead Sponsor

Shanghai Dermatology HospitalOTHER

Collaborators

Peking University People's HospitalOTHER

Xiangya Hospital of Central South UniversityOTHER

Central South UniversityOTHER

Wuhan No.1 HospitalOTHER

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Tripler Army Medical CenterFED

Second Affiliated Hospital of Xi'an Jiaotong UniversityOTHER

Chinese PLA General HospitalOTHER

Henan Provincial People's HospitalOTHER

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