The role of the 595-nm pulsed dye laser in treating superficial basal cell carcinoma: outcome of a double-blind randomized placebo-controlled trial.

BACKGROUND: Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas (BCCs). However, robust supporting evidence is lacking due to inconsistent design of available studies. OBJECTIVES: To evaluate PDL efficacy and safety in treating superficial BCC (sBCC) at low-risk anatomical sites in an evidence-based study setting. MATERIALS AND METHODS: Thirty-nine patients (27 men and 12 women, 75·9 ± 10 years) with a total of 100 sBCCs were randomized to receive PDL treatment (wavelength 595 nm; fluence 8 J cm(-2) ; pulse duration 0·5 ms; spot size 10 mm) or sham treatment. The primary endpoint was complete clinical and histological remission of the tumour at 6-month follow-up; the secondary endpoints were the evaluation of side-effects and pain as well as patient satisfaction. RESULTS: The primary endpoint showed significant superiority of the laser group to the sham group (P < 0·0001). Complete remission was achieved in 44 of 56 cases (78·6%) in the laser and in two of 44 cases (4·5%) in the sham treatment arm. The main adverse events in the laser group were crusts, hyper- and hypopigmentation. An average of 72% of patients stated at the individual sessions that they were 'satisfied' with the laser treatment, whereas 25% were 'very satisfied'. CONCLUSIONS: PDL is an effective and safe method for treating sBCC. However, the occurrence of persistent dyspigmentation still limits the potential for excellent cosmetic outcomes.

[Efficacy of a manual treatment method according to the fascial distortion model in the management of contracted ("frozen") shoulder]. / Wirksamkeit einer manuellen Behandlungstechnik nach dem Fasziendistorsionsmodell bei schmerzhaft eingeschränkter Schulterbeweglichkeit (Frozen Shoulder).

BACKGROUND: Frozen shoulder is a common problem and difficult to treat. The present prospective randomised single-blind controlled trial evaluates the efficacy of the 'fascial distortion model' according to Typaldos as a remedy for the 'frozen shoulder'. MATERIALS AND METHODS: A total of 60 patients were randomised to receive either the FDM-guided treatment (FDM, n = 30) or a 'conventional' manual therapy (MT, n = 30). The primary endpoint for the treatment effect was the shoulder mobility, and secondary endpoints were pain (measured on a VAS), raw force and function as expressed by the Constant-Murley and DASH scores. RESULTS: Before therapy, groups were well comparable in terms of all outcome parameters. All endpoints showed a substantial and significant improvement in both treatment groups. Improvement was significantly more marked in the FDM group as compared to the MT group, and the effect occurred significantly faster. During post-treatment observation, there was no further improvement and the achieved benefit in mobility in the FDM group decreased. However, the abduction ability of 150.2 ± 37.2° continued to be substantially better than in control patients (124.1 ± 38.6°, p < 0.01), and the ultimate improvement in abduction was 59.4° (64 % more than baseline) as opposed to 25.9° (27 %) in controls. Secondary outcome parameters (raw force, functional handicap, and pain) showed a significant improvement in both groups but a significantly better result in patients treated according to FDM guidelines. However, patients in this group experienced pain during the treatment more frequently (21/27 vs. 10/27, p < 0.01). CONCLUSION: Frozen shoulder treatment according to the FDM is an effective modality with swift onset of action and acceptable side effects that is superior to conventional manual therapy. Long-term effects and modes of action need to be investigated.

Is non-ablative 1550-nm fractional photothermolysis an effective modality to treat melasma? Results from a prospective controlled single-blinded trial in 51 patients.

BACKGROUND: Melasma is a common benign pigmentary disease and can pose a substantial therapeutic challenge. Although the use of non-ablative fractional photothermolysis (NFP) has gained much popularity, there are still very few evidence-based data supporting NFP in the treatment of melasma. OBJECTIVE: To assess the efficacy and safety of NFP for the treatment of melasma in a controlled observer-blinded parallel-group study. PATIENTS AND METHODS: Fifty-one patients [90.2% women, 9.8% men; mean age 40.3±6.1 (control group) and 41.7±11.4 (treatment group)] received a broad-spectrum sunscreen either alone (n=25; 49.0%) or in combination with a 1550-nm NFP treatment (n=26; 51.0%) [energy: 15 mJ/microthermal zone (MTZ); total density: 1048 MTZs/cm(2); density per pass: 131 MTZs/cm(2); number of passes: 8; total coverage: 20%]. Four sessions of NFP treatment were performed at 3-week intervals on each subject in the treatment group. Patients were evaluated at baseline and 12 weeks after final treatment. The primary efficacy variables were the Melasma Area and Severity Index (MASI) and the physician's global assessment (PGA); secondary efficacy variables were the patients' subjective assessment of improvement and patient satisfaction. Safety was evaluated through the reporting of adverse events. RESULTS: The percentage of subjective improvement was virtually identical in both groups: one-third of the patients reported a 'marked improvement' and another half reported 'some improvement'. Twenty-three patients in each group declared that they were 'satisfied' with the treatment result. The MASI corroborated the patients' subjective estimate, both in terms of the degree of improvement and the lack of a group difference. In both groups, the MASI score and the PGA were reduced significantly after therapy, and the reduction was also clinically relevant. No serious side-effects were reported in either group. CONCLUSION: Our findings do not support the hypothesis of NFP providing a substantial benefit in treating melasma when compared with the lone application of a broad-spectrum sunscreen.