NCT03596619

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Shanghai Dermatology Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-30
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2018-07-24
• Last updated: 2019-03-19

Locations

2 sites across 1 country: China