The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis
NCT ID: NCT03596619
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2018-08-30
2021-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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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).
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.
ALA-PDT Group
The ALA-PDT group received ALA cream and irradiation only.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Central South University
OTHER
Wuhan No.1 Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Tripler Army Medical Center
FED
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Chinese PLA General Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Shanghai Dermatology Hospital
OTHER
Responsible Party
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Xiuli Wang
Institute of Photomedicine
Principal Investigators
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Xiuli Wang, PhD, MD
Role: STUDY_CHAIR
Shanghai Skin Disease Hospital
Locations
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Shanghai Dermatology Hospital
Shanghai, Jingan, China
Xiuli Wang
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Peiru Wang
Role: backup
References
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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.
Other Identifiers
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2018-05
Identifier Type: -
Identifier Source: org_study_id
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