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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Central South University | OTHER |
| Wuhan No.1 Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBN-ALA-PDT Group | Experimental | 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). |
|
| ALA-PDT Group | No Intervention | The ALA-PDT group received ALA cream and irradiation only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBN | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment sessions | Number of treatment sessions required for clinical cure | two weeks after the last session |
| Number of new Actinic Keratoses | The change in number of actinic keratoses at each follow-up will be measured as the second outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peiru Wang, PhD | Contact | 021-18017336579 | wpeiru@qq.com | |
| Lude Zhu, MD | Contact | 021-15821804557 | zhulude0318@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Wang, PhD, MD | Shanghai Skin Disease Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dermatology Hospital | Recruiting | Shanghai | Jingan | 200443 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25950503 | Result | 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. | |
| 27375183 |
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underlie results
One year after finishing this study and for permanency
anyone who search pubmed
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| 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 |
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|
| 1, 3, 12 months after last session |
| Adverse events | Measurement of crusting, erythema, edema, pain and et al. | 1, 3, 12 months after last session |
| Xiuli Wang | Recruiting | Shanghai | Shanghai Municipality | 200443 | China |
|
| Result |
| 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. |
| 22136038 | Result | 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. |
| 6567734 | Result | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |