5-ALA loaded self-adhesive patch-PDT is effective and safe in the treatment of actinic keratoses on hands and arms.

Photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (ALA) is an established method for the management of AK. PD P 506 A (brand name Alacare®) is an approved medicinal product for the treatment of AK located on scalp and face. It is a self-adhesive, light-proof patch loaded with 5-ALA HCl and was developed for easy handling. AK located on arms, hands or trunk do not respond as well to ALA-PDT as AK lesions on the head do. It has been reported that occlusion during ALA incubation can improve clinical outcome after ALA-PDT for AK on hands and arms. We present the results of a first explorative pilot study involving 20 participants with a total of 145 treated (122 evaluable) AK lesions. The trial investigated the conduct of two ALA-PDTs within 1-2 weeks and involved all severity grades of AK. The model-based percentage of complete clearance on lesion-basis was estimated being 78.0% (95%-CI: [64.6%, 87.3%]), and the by-participant calculation (patient-based clearance) led to similar results (78.7% with a 95%-CI of [67.0%, 90.3%]). The treatment was well tolerated. Local reactions during ALA patch incubation were rare whereas nearly all patients showed the expected reactions during or after the illumination, primarily erythema and pain. The study results indicate that two PD P 506 A-PDT sessions 1-2 weeks apart are an efficacious treatment for AK on hands and arms. Especially mild but also moderate lesions responded very well to PDT treatment involving ALA incubation under occlusion.

Photodynamic therapy with a 5-ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma: Results of a multicentre non-interventional study.

BACKGROUND: It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5-ALA patch for a longer follow-up period under daily routine. QUESTIONS ADDRESSED: The purpose of this non-interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5-ALA patch-PDT. EXPERIMENTAL DESIGN: This prospective observational case-only study included patients with mild AK lesions on the head and face treated with 5-ALA patch-PDT according to the Summary of Product Characteristics (SPC). RESULTS: In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%. CONCLUSION: The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5-ALA patch-PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.

Effective photodynamic therapy of actinic keratoses on the head and face with a novel, self-adhesive 5-aminolaevulinic acid patch.

BACKGROUND: Photodynamic therapy (PDT) is increasingly used for the treatment of actinic keratosis (AK). OBJECTIVES: To investigate both the efficacy of different application times and the safety of a novel patch (PD P 506 A) containing aminolaevulinic acid in the PDT of mild to moderate AK. METHODS: Applications of PD P 506 A for 0.5, 1, 2 and 4 h were compared in a multicentre, randomized, blinded-observer, parallel-group study. After patch removal, study lesions were illuminated with red light (lambda(em) approximately 630 nm; 37 J/cm(2)). Study lesions were not pretreated (e.g. by curettage) prior to PDT. Efficacy was evaluated 4 and 8 weeks after treatment. Safety and tolerability were determined through laboratory analyses and documentation of both local reactions and adverse events. RESULTS: A total of 149 patients were initially enrolled. Of these, 140 patients (520 lesions) completed the study according to protocol. Eight weeks after treatment, 86% of the AK lesions (74% of the patients) treated with 4-h patch application showed complete clearance. The complete clearance rates of lesions (patients) for the 2-, 1- and 0.5-h treatment arms were 73% (47%), 72% (50%) and 51% (24%), respectively. Statistically, the 4-h application was identified as the 'best treatment'. Patients with clearance seemed to experience local reactions to a greater extent than patients without clearance. Local reactions to study treatments did not exceed the expected range. CONCLUSIONS: The results of this first clinical efficacy study suggest excellent therapeutic outcomes with a single PD P 506 A PDT with a 4-h application.

Adjuvant photodynamic therapy does not prevent recurrence of condylomata acuminata after carbon dioxide laser ablation-A phase III, prospective, randomized, bicentric, double-blind study.

BACKGROUND: Recurrence after therapy for anogenital warts, or condylomata acuminata (CA), is common. Topical photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) is efficient in the treatment of CA, but one problem with PDT is the limited penetration depth of photosensitizer and light. Pre-PDT vaporization of CA using a carbon dioxide (CO(2)) laser may enhance efficacy. OBJECTIVES: CO(2) laser ablation was followed by ALA-PDT in a phase III prospective randomized bicenter double-blind study to prevent recurrence of CA. MATERIALS AND METHODS: One hundred seventy-five patients with CA received CO(2) laser vaporization plus adjuvant ALA-PDT (n=84) or adjuvant placebo-PDT (n=91). A 20% ALA or placebo ointment was applied to the CA area 4 to 6 hours before CO(2) laser vaporization, followed by illumination with red light (600-740 nm, 100 mW/cm(2), 100 J/cm(2)). RESULTS: Cumulative recurrence rate 12 weeks after treatment was 50.0% in the ALA-PDT group, versus 52.7% in the placebo-PDT group (p=.72). No statistically significant difference between groups was detected with regard to recurrence rates up to 12 months after treatment. No major complications were observed. CONCLUSION: Adjuvant ALA-PDT of CA after CO(2) laser ablation was well tolerated, but no significant difference with regard to recurrence rate was observed from CO(2) laser vaporization alone.