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

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596619
• Other study ID #: 2018-05
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2019
• Source: Shanghai Dermatology Hospital
• Contact: Peiru Wang, PhD
• Phone: 021-18017336579
• Email: wpeiru[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Dermatology Hospital	Shanghai	Jingan
China	Xiuli Wang	Shanghai	Shanghai

Sponsors (10)

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

Country where clinical trial is conducted

China, 

References & Publications (4)

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: 10.101 — View Citation

Jia XH, Liu LN. [Plum blossom needling for 74 cases of scapulohumeral periarthritis]. Zhongguo Zhen Jiu. 2011 Nov;31(11):1040. Chinese. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment sessions	Number of treatment sessions required for clinical cure	two weeks after the last session
Secondary	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
Secondary	Adverse events	Measurement of crusting, erythema, edema, pain and et al.	1, 3, 12 months after last session