A study reported late last year was carried out to determine whether prior microneedling would enhance the penetration of topical aminolevulinic acid HCl (Levulan) and thus enhance photodynamic therapy (PDT) and possibly also result in a better cosmetic outcome vs PDT alone in patients with AKs.
In this trial, 20 patients each with ≥4 non-hyperkeratotic AKs on each side of their faces were randomized to receive multiple passes with a microneedling device on one side of their faces, followed by application of aminolevulinic acid HCl to the entire face.
The aminolevulinic acid HCl was allowed to incubate for 1 hour and this was followed by exposure to blue light (Blu U) for 1000 seconds.
For the 19 patients who completed 4 months of follow-up, the mean AK reduction on the microneedling side was 89.3% vs 69.5% on the PDT alone side. In addition, 13 of the 19 patients had a noticeable improved cosmetic appearance on the microneedled side of the face (Spencer, 2016).
No, Its Red
Aminolevulinic acid hydrochloride (BF-200 ALA, Ameluz) was recently approved by the United States Food and Drug Administration for PDT using the BF-RhodoLED lamp, a narrowband, red light illumination source, for lesion-directed and field-directed treatment of AKs of mild-to-moderate severity on the face and scalp.
This approval was based on results from 779 patients with 4-8 mild to moderate AK lesions. The results obtained from these studies demonstrated that BF-200 ALA was significantly superior to the standard of care, with a complete patient response rate of 91% when paired with BF-RhodoLED PDT lamp (CenterWatch, 2017).
In addition, BF-200 ALA showed positive long-term effects with low recurrence over the course of 12 months (Dirschka, 2013).
In a pivotal phase III trial performed on entire treatment fields, BF-200 ALA demonstrated long-lasting skin rejuvenation effects in sun-damaged, but asymptomatic, skin regions (CenterWatch, 2017; Reinhold, 2016).
CenterWatch. Ameluz (aminolevulinic acid hydrochloride). 2017. Available at: http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100150/ameluz-aminolevulinic-acid-hydrochloride
Dirschka T, Radny P, Dominicus R, et al. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013;168:825-36.
Reinhold U, Dirschka T, Ostendorf R, et al. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz(®) ) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp. Br J Dermatol. 2016;175:696-705.
Spencer JM, Freeman SA. Microneedling Prior to Levulan PDT for the Treatment of Actinic Keratoses: A Split-Face, Blinded Trial. J Drugs Dermatol. 2016;15:1072-4.