The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Completed 32 enrolled University of California, Davis

RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Timeline

Start: 2014-11-06
Primary completion: 2016-06-22
Completion: 2016-06-22

Outcome

Mixed primary results

paper For the 20-minute incubation arm, average AK clearance was 76% vs 58% on the sham side (P < .01) PMID 28514458 ↗

paper For the 10-minute incubation arm AK clearance for the microneedle pretreated side was 43% compared with 38% on the sham side (P = .66). PMID 28514458 ↗

Publications

Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminolevulinic Acid	Diagnostic / imaging agent	—	Topical