Single vs. fractionated photodynamic therapy for face and scalp actinic keratoses: a randomized,intraindividual comparison trial with 12‐month follow‐up

Objective To compare the efficacy and tolerability of a single ALA‐PDT illumination scheme with that of a fractionated ALA‐PDT illumination scheme in face and scalp actinic keratoses (AKs). Methods Eligible patients received either a single ALA‐PDT illumination or a fractionated illumination scheme randomly allocated to alternate sides of face/scalp. The side allocated to a single illumination received 75 J/cm². This side received 2 sessions performed 7 days apart. Lesions on the fractionated illumination scheme side received 20 and 80 J/cm², 4 and 6 hours after a single ALA application. Patients were evaluated at baseline, at 3 and 12 months after treatment. Efficacy end point included the individual AK lesion clearance rate. Results Thirty three patients with 266 lesions were enrolled in the study. Three months after treatment the overall lesion complete response rate was 89.05% for the single scheme and 96.12% for the fractionation scheme while at the 12‐months follow‐up response rate decreased to 85.4% for the single illumination and to 93.79% for the fractionated illumination group. Looking at lesion response based on lesion grade fractionated photodynamic therapy (PDT) resulted in larger rates of cured grade I as well as grade II lesions. Recorded adverse events were transient and did not demand additional therapy. Conclusions Our results demonstrate that higher responses are achieved with fractionated PDT compared with single illumination PDT. The study data indicate that fewer treatment sessions may be needed with fractionated PDT increasing that way the comfort of the patient regarding number of visits, treatment cost and treatment‐related downtime.     

Multicentre study ‘rehabilitation of occupational skin diseases –optimization and quality assurance of inpatient management (ROQ)’–results from 12‐month follow‐up

Background. Occupational skin disease (OSD) is common, and imposes a considerable personal and public burden. To tackle OSD, the German stepwise procedure of handling OSD was set up. It contains an interdisciplinary, integrated inpatient rehabilitation measure [tertiary individual prevention (TIP)] [dermatological treatment and diagnostic procedures, and patient education (health and psychological)]. The primary aims of the TIP are reduction of the severity of OSD, reduction in the use of corticosteroids, facilitation of return to work, decreased absence from work, and enhanced quality of life (QoL). It was positively evaluated for a period of 4 weeks after return to work. Objectives. To investigate whether the observed short‐term effects remain significant and meaningful over a period of 12 months after discharge from the TIP. Methods. A prospective design was used to compare clinical and patient‐reported outcome data between admission to a 3‐week inpatient TIP and 12 months after discharge (12‐month follow‐up). Results. Of 1788 individuals admitted to the TIP, data from 1617 individuals were available for analysis. We observed a significant reduction in the severity of OSD, the use of topical corticosteroids, and days of absence from work because of OSD. QoL was significantly improved, and 87.4% were able to return to work and remain in the workforce. Conclusions. A randomized controlled trial would have been desirable, but was not possible, for legal and other reasons. However, the long‐term 12‐month follow‐up shows that the TIP is associated with sustained improvements in terms of ability to work, QoL, and prognosis, and reductions in days of absence from work because of skin conditions and topical corticosteroid application. These results indicate that the TIP provided a reduction in the personal and public burden of OSD.     

A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8–20 mm), with a 12‐month follow‐up.

Objective To compare the efficacy and cosmetic outcome (CO) of photodynamic therapy with topical methyl aminolevulinate (MAL‐PDT) with simple excision surgery for superficial basal cell carcinoma (sBCC) over a 1‐year period. Methods In this multicentre, randomised, controlled, open study, patients were treated at baseline either with MAL‐PDT (two sessions, 7 days apart, repeated 3 months later if incomplete clinical response) or surgery (at baseline). Primary endpoints were clinical lesion response (CR) 3 months after last treatment and CO assessed by the investigator 12 months after last treatment. Secondary endpoints were CR at 12 months (i.e. recurrence) and CO assessed by the investigator at 3 and 6 months and by the patient at 3, 6 and 12 months. Results Overall, 196 patients were enrolled with 1.4 sBCC lesions on average per patient. Mean lesion count reduction at 3 months was 92.2% with MAL‐PDT vs. 99.2% with surgery [per protocol (PP) population] confirming the non‐inferiority hypothesis (95% confidence interval, –12.1, –1.9). A total of 92.2% lesions showed CR at 3 months with MAL‐PDT vs. 99.2% with surgery (PP population). At 12 months, 9.3% lesions recurred with MAL‐PDT and none with surgery. CO was statistically superior for MAL‐PDT at all time points. At 12 months, 94.1% lesions treated with MAL‐PDT had an excellent or good CO according to the investigator compared with 59.8% with surgery. This difference was confirmed with the patients’ assessment. The proportion of excellent CO markedly improved with time with MAL‐PDT unlike surgery. Conclusions MAL‐PDT offers a similarly high efficacy and a much better CO than simple excision surgery in the treatment of sBCC.     

Long‐term follow‐up of photodynamic therapy with a self‐adhesive 5‐aminolaevulinic acid patch: 12 months data

Background Photodynamic therapy with a self‐adhesive 5‐aminolaevulinic acid (5‐ALA) patch shows high efficacy rates in the treatment of mild to moderate actinic keratosis (AK) in short term trials. Objectives The purpose of the trial was to follow up patients after successful 5‐ALA patch‐PDT at 3 month intervals over a total period of 12 months. Patients who had received placebo‐PDT or cryosurgery served for comparison. Patients/methods Three months after therapy, 360 patients from two separate randomized parallel group phase III studies (one superiority trial vs. placebo‐PDT, one noninferiority trial vs. cryosurgery) were suitable for the follow‐up study. Patients had to show at least one successfully treated AK lesion after initial therapy. A total of 316 patients completed the follow‐up. Results Twelve months after a single treatment, 5‐ALA patch‐PDT still proved superior to placebo‐PDT and cryosurgery (P < 0·001 for all tests). On a lesion basis, efficacy rates were 63% and 79% for PDT, 63% for cryosurgery and 9% and 25% for placebo‐PDT. Recurrence rates of patch‐PDT proved superior to those of cryosurgery (per protocol set: P = 0·011, full analysis set: P = 0·049). While 31% of cryosurgery lesions were still hypopigmented after 1 year, the 5‐ALA patch‐PDT groups showed hypopigmentation in 0% (superiority trial) and 3% (noninferiority trial) of the treated lesions. Conclusion Twelve months after a single 5‐ALA patch‐PDT the majority of lesions were still cleared with an excellent cosmetic outcome. 5‐ALA patch‐PDT proved to be superior to cryosurgery in the noninferiority study setting.     

Photodynamic therapy with 5‐aminolevulinic acid in actinic cheilitis: an 18‐month clinical and histological follow‐up

Background Actinic cheilitis (AC) may bear the initial and superficial changes of actinically induced squamous cell carcinoma (SCC) and may progress into fully developed SCCs. Early and effective treatment is important. Objective To assess the clinical and histological long‐term outcome in AC after two ALA‐PDT sessions. Methods Patients with histologically proven grade 1 and 2 AC received two ALA‐PDT sessions at 2 weeks interval. Subjects with complete clinical response at 3 months were evaluated further clinically and histologically at months 6, 12 and 18. Long‐term study outcome was defined as clinical and histological AC recurrence among patients with complete clinical response 3 months after treatment. Cosmetic outcome was assessed by the investigators at the final follow‐up visit at 18 months. Results Of the 40 patients enrolled, 38 completed the study. Complete clinical response at 3 months was achieved in 26 patients. At 6 months, clinical and histological recurrence occurred in three patients and at 12 months, one more patient showed clinical and histological recurrence. At 18 months, overall clinical recurrence rate was 15.38% (4/26), while overall histological recurrence rate was 34.61% (9/26). Cosmetic outcome was rated as excellent in more than 80% of evaluated cases. Conclusion PDT represents a moderately effective treatment modality in AC. Optimization of treatment procedure and protocols is still needed for higher response rates to be achieved. Moreover, the high treatment cost should be given consideration. Further long‐term follow‐up studies are needed for assessment of clinical and histological very late recurrences that could be expected after PDT.