A randomized intraindividual comparative study of methyl-5-aminolaevulinate vs. 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) in photodynamic therapy for actinic keratosis of the face and scalp

Serra‐Guillén, C.; Nagore, Eduardo; Bancalari, Eugenia; Kindem, S.; Sanmartín, O.; Llombart, B.; Requena, Celia; Serra-Guillén, I.; Calomarde, L.; Diago, A.; Bernia, E.; Guillén, C.

doi:10.1111/bjd.17014

Cited by 14 publications

(14 citation statements)

References 8 publications

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“…Patient tolerability may be as important as efficacy in chronic disease, and the severity of skin reactions (erythema and crusting) was significantly worse for BF‐200 ALA; 26 patients had a stronger skin reaction on the BF‐200 ALA side, with seven on the MAL side and 23 displaying no difference ( P = 0·001). Another study comparing MAL with BF‐200 ALA also showed better tolerability of MAL, which is probably due to better specificity for dysplastic cells . In accordance with previous studies, pain was slightly lower with MAL (1·51 BF‐200 ALA vs. 1·35 MAL).…”

supporting

confidence: 84%

A randomized, double‐blind trial comparing 5‐aminolaevulinic acid nanoemulsion with methyl 5‐aminolaevulinate in daylight photodynamic therapy for actinic keratosis

Szeimies

Calzavara‐Pinton

2019

Br J Dermatol

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supporting

confidence: 84%

A randomized, double‐blind trial comparing 5‐aminolaevulinic acid nanoemulsion with methyl 5‐aminolaevulinate in daylight photodynamic therapy for actinic keratosis

Szeimies

Calzavara‐Pinton

2019

Br J Dermatol

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“…59 A randomized intra-individual study of 50 patients compared nanoemulsion ALA with MAL, demonstrating similar lesion clearance rate after a single treatment (ALA: 90%, MAL: 88%) but with more intense skin reactions observed with ALA, presumed due to less selectivity, although this was associated with higher accumulation of PpIX. 60 One year of lesion clearance rates of 78% and 63-79% have been reported following Levulan ALA-PDT (up to two treatments) and patch ALA-PDT (single treatment), respectively. 39,61 A randomized multicentre study of conventional nanoemulsion ALA-PDT achieved a patient clearance rate of 91% (vs. 22% placebo) with additional benefits to skin quality in field-directed treatment of AK.…”

Section: Current Indicationsmentioning

confidence: 99%

European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas

Morton¹,

Szeimies

Basset-Séguin

et al. 2019

Acad Dermatol Venereol

148

146

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Topical photodynamic therapy (PDT) is a widely approved therapy for actinic keratoses, Bowen's disease (squamous cell carcinoma in situ), superficial and certain thin basal cell carcinomas. Recurrence rates when standard treatment protocols are used are typically equivalent to existing therapies, although inferior to surgery for nodular basal cell carcinoma. PDT can be used both as lesional and field therapies and has the potential to delay/reduce the development of new lesions. A protocol using daylight to treat actinic keratoses is widely practised, with conventional PDT using a red light after typically a 3‐h period of occlusion employed for other superficial skin cancer indications as well as for actinic keratoses when daylight therapy is not feasible. PDT is a well‐tolerated therapy although discomfort associated with conventional protocol may require pain‐reduction measures. PDT using daylight is associated with no or minimal pain and preferred by patient. There is an emerging literature on enhancing conventional PDT protocols or combined PDT with another treatment to increase response rates. This guideline, published over two parts, considers all current approved and emerging indications for the use of topical PDT in dermatology, prepared by the PDT subgroup of the European Dermatology Forum guidelines committee. It presents consensual expert recommendations reflecting current published evidence.

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“…Diclofenac/HA showed rather low clearance rates of 35% in the meta-analysis of single-armed studies and was also inferior in a direct comparison to imiquimod, which is in line with the results from previous RCTs [ 27 , 28 ]. Participant complete clearance rates for ALA-PDT strongly contrast with findings from pivotal RCTs in which at least twice as many patients achieved complete clearance of their AKs [ 29 , 30 ]. In contrast, complete clearance for IMB in this analysis was almost twice as high as reported by a pivotal phase III RCT comparing IMB to placebo [ 31 ].…”

Section: Discussionmentioning

confidence: 87%

A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials

Steeb

Wessely

Harlaß

et al. 2020

JCM

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Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance studies have received little attention until now. Here, we systematically investigate interventions for AK from post-marketing surveillance trials as a proxy for real-world efficacy and tolerability. A systematic literature search was conducted in Medline, Embase, and CENTRAL. Pertinent trial registers were hand-searched until 25 March 2020. Results were pooled using a random-effects model to calculate pooled proportions and relative risks (RR) or were described qualitatively. Eleven records with a total sample size of n = 4109 were included. Three of the studies had an active-controlled design, while seven were single-armed. Participant complete clearance ranged from 23.1% for diclofenac sodium 3% gel to 88.9% for ingenol mebutate 0.05% gel. The lesion-specific clearance rate for photodynamic therapy (PDT) was 74% (95% confidence interval (CI) 56–87%). The recurrence rate was significantly higher for diclofenac sodium 3% in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02–1.1.8) and ranged from 10.6% for ingenol mebutate 0.015% gel to 23.5% for PDT. Few patients discontinued the trials due to adverse events. The results from the majority of the post-marketing surveillance studies deviated from those of pivotal trials.

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A randomized intraindividual comparative study of methyl-5-aminolaevulinate vs. 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) in photodynamic therapy for actinic keratosis of the face and scalp

Cited by 14 publications

References 8 publications

A randomized, double‐blind trial comparing 5‐aminolaevulinic acid nanoemulsion with methyl 5‐aminolaevulinate in daylight photodynamic therapy for actinic keratosis

A randomized, double‐blind trial comparing 5‐aminolaevulinic acid nanoemulsion with methyl 5‐aminolaevulinate in daylight photodynamic therapy for actinic keratosis

European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas

A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials

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