Microneedle‐assisted incubation during aminolaevulinic acid photodynamic therapy of actinic keratoses: a randomized controlled evaluator‐blind trial

Lev‐Tov, Hadar; Larsen, Larissa N; Zackria, Rasiq; Chahal, Harvind S.; Eisen, Daniel B.; Sivamani, Raja K

doi:10.1111/bjd.15116

Cited by 15 publications

(14 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The study confirms and expands on the MNPDT-I pilot study that showed equivalent complete AK clearance rates between 20-minute ALA incubation with microneedle pretreatment vs traditional PDT with 1-hour incubation. 13 The AK clearance rate in the MNPDT-II trial is similar to those in previous investigations of traditional PDT with ALA incubation times of 1 hour (78.6%), 2 hours (76.5%), and 3 hours (80.0%) at the 12-week follow up. 2 An even shorter incubation time was investigated under occlusion of an ALA patch for 30 minutes but showed AK clearance rates of only 47% at the 4-week follow up.…”

Section: Discussionsupporting

confidence: 82%

“…6 In fact, adequate photosensitizer was detected by fluorescence dosimetry in as little as 30 minutes after application of methyl aminolevulinic acid after microneedle pretreatment. 8,16 Our previous investigation 13 demonstrated equivalent efficacy of complete AK clearance on the forehead (71.4% vs 68.3%; P > .05) in expedited microneedle PDT with 20-minute ALA incubation vs the standard 1-hour incubation with sham microneedle pretreatment. The current study aimed to expand on these findings and investigate the efficacy of expedited ALA PDT with microneedle pretreatment at short ALA incubation times in a randomized clinical trial.…”

mentioning

confidence: 94%

See 1 more Smart Citation

Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses

et al. 2017

View full text Add to dashboard Cite

IMPORTANCE Photodynamic therapy (PDT) is an effective and cosmetically favorable treatment modality for actinic keratoses (AKs). However, prolonged incubation times and pain associated with treatment are burdensome to the patient and a hindrance to widespread use of PDT as standard field therapy for AK. OBJECTIVE To evaluate efficacy and pain associated with microneedle expedited PDT. DESIGN, SETTING, AND PARTICIPANTS The Microneedle Photodynamic Therapy II (MNPDT-II) study was a randomized, single-blinded, split-face controlled, 2-arm clinical trial. Thirty-three participants with AK on the face were recruited in a university dermatology outpatient clinic from 2015 to 2016, and 32 participants completed the study. INTERVENTIONS Participants were randomized into 2 incubations arms, either 10-minute or 20-minute aminolevulinic acid (ALA) incubation times, after pretreatment with a microneedle roller (200 um) vs a sham roller. They were blinded to the laterality of microneedle and sham roller assignments. After incubation, they were exposed to blue light (Blu-U, Dusa Pharmaceuticals) for 1000 seconds for a total fluence of 10 J/cm 2. MAIN OUTCOMES AND MEASURES The primary outcome was to quantitatively measure AK resolution, and the secondary outcome was to assess pain associated with microneedle pretreatment. RESULTS Thirty-three individuals were recruited and randomized to either the 20-minute or the 10-minute incubation arm. Thirty-two participants completed the study with a mean follow-up time of 34.5 days in the 20-minute group, and 30.2 days in the 10-minute group. For the 20-minute incubation arm, average AK clearance was 76% vs 58% on the sham side (P < .01), including 3 patients with complete clearance, although not statistically significant (P = .25). Pain assessment on the visual analog scale (VAS) during blue light illumination was not significantly different between the microneedle and sham sides (0.7 and 0.4; P = .28), respectively. For the 10-minute incubation arm AK clearance for the microneedle pretreated side was 43% compared with 38% on the sham side (P = .66). Pain during the blue light exposure was not significantly different between the microneedle and sham sides, 4.5 mm and 3.4 mm (P = .21), respectively. CONCLUSIONS AND RELEVANCE Photodynamic therapy with microneedle pretreatment at a 20-minute ALA incubation time significantly improved AK clearance with efficacy similar to that of a conventional 1-hour ALA incubation time. The additional advantage to expedited treatment was that the procedure was virtually painless. However, expedited exposure of a 10-minute ALA incubation time did not reach significantly different AK clearance from the sham control. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02594644

show abstract

Section: Discussionsupporting

confidence: 82%

mentioning

confidence: 94%

Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Moreover, there is an increase in transepidermal drug delivery, for, at least, 72 h after the procedure. This can also increase the effect of triple association on the melanogenesis [ 29 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

Assessment of the effects of skin microneedling as adjuvant therapy for facial melasma: a pilot study

Lima

Paixão

et al. 2017

BMC Dermatol

View full text Add to dashboard Cite

BackgroundMelasma is a common chronic and relapsing acquired dyschromia. Skin microneedling was reported resulting sustained long-term improvement of recalcitrant melasma, however, the exact mechanism that promotes this skin lightening is not known. This study aimed to investigate clinical and histologic alterations promoted by skin microneedling in facial melasma.MethodsOpen pilot trial including six women with facial refractory melasma submitted to two sessions of microneedling (1.5 mm) each 30 days followed by daily triple combination and broad-spectrum sunscreen. Comparison of pretreatment (T0) and 15 days after last microneedling procedure (T45) was made by standardized pictures, skin colorimetry, MASI, MELASQoL and histological parameters (haematoxylin-eosin, picrosirius-red, periodic acid Schiff and Fontana-Masson staining).ResultsThe age of the subjects varied from 34 to 46 years-old, the phototypes were III and IV (Fitzpatrick), and age of melasma onset was 20 to 38 years. Improvement of melasma was perceived in all subjects. There was a significant reduction of MASI score (−70%), MELASQoL (−55%) and increase in L* (+13%) colorimetric value (p < 0.03). All cases evidenced epithelium thickening, decrease in melanin pigmentation and densification of upper dermis collagen (p = 0.03). Patients were followed by 6 months under broad-spectrum sunscreen and triple combination without relapse.ConclusionIn addition to classic treatment (broad-spectrum sunscreen and triple combination), skin microneedling promoted clinical and histological improvement of refractory facial melasma.

show abstract

“…3 Patient before and after treatment of multiple AK with ablative fractionated CO 2 10,600 nm laser + PDT Microneedle-assisted PDT (MN-PDT). MN devices are micrometer-scale needles capable of puncturing the stratum corneum with minimal pain, shortening the incubation time for ALA and enhancing the efficacy of PDT [ 25 ]. MN-PDT can achieve an increase in mean lesion clearance; the photosensitizer is applied first then the MN-PDT is performed [ 26 , 27 ].…”

Section: Therapeutic Managementmentioning

confidence: 99%

Management Pearls on the Treatment of Actinic Keratoses and Field Cancerization

Piquero-Casals¹,

Morgado‐Carrasco

Gilaberte

et al. 2020

Dermatol Ther (Heidelb)

View full text Add to dashboard Cite

Field cancerization (FC) is a chronic disease involving multiple clinical and subclinical actinic keratoses (AK) on large photo-exposed surfaces with multifocal areas of dysplasia and precancerous changes. Patients and treatment must be properly monitored and managed to avoid aggravation and progression of the disease. Management of actinic keratoses includes lesion-directed treatments, such as cryotherapy and field-directed therapies. Field-directed therapies may have the potential to address subclinical damage, reduce AK recurrence rates and potentially reduce the risk of squamous cell carcinoma development. Multiple studies have demonstrated the efficacy of field-directed treatments, including 5-fluorouracil, photodynamic therapy, imiquimod, chemical exfoliation with trichloroacetic acid and diclofenac gel, for multiple AK and FC. The choice of therapy should be based on multiple factors, such as efficacy, tolerability, patient risk profile, costs and cosmetic results. Management of AK includes not only treatment but also prevention. Medical devices, such as sunscreens containing liposome-encapsulated DNA repair enzymes, can repair DNA damage associated with chronic UV radiation and reduce the number of new AK lesions. Here we provide therapeutic pearls and expert opinions on the treatment of AK and FC (as monotherapy or in combination) with the overall aim to achieve better, faster, and well-tolerated clinical responses.

show abstract

Microneedle‐assisted incubation during aminolaevulinic acid photodynamic therapy of actinic keratoses: a randomized controlled evaluator‐blind trial

Cited by 15 publications

References 10 publications

Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses

Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses

Assessment of the effects of skin microneedling as adjuvant therapy for facial melasma: a pilot study

Management Pearls on the Treatment of Actinic Keratoses and Field Cancerization

Contact Info

Product

Resources

About