Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBN | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PBN-ALA-PDT Group
- 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).
- interventionNames
- Device: PBN
- type
- NO_INTERVENTION
- label
- ALA-PDT Group
- description
- The ALA-PDT group received ALA cream and irradiation only.
Primary outcomes (1)
- measure
- The clearance rate of Actinic Keratoses
- timeFrame
- two weeks after first session
- description
- The change rate in lesion clearance of Actinic Keratoses at two weeks after the first session will be measured as the primary outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTPomerantz 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. PMID 25950503
- RESULTChen 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. PMID 27375183
- RESULTJia XH, Liu LN. [Plum blossom needling for 74 cases of scapulohumeral periarthritis]. Zhongguo Zhen Jiu. 2011 Nov;31(11):1040. No abstract available. Chinese. PMID 22136038
- RESULTYao 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. PMID 6567734