Treatment of venous malformations: first experience with a new sclerosing agent--a multicenter study.

PURPOSE: To study the efficacy and safety of a new sclerosing gel of absolute ethanol in the percutaneous treatment of venous malformations (VM). MATERIALS AND METHODS: In this prospective, non-randomized multicenter study patients with clinically and by magnetic resonance imaging diagnosed VM were treated. Efficacy and safety of the gel was evaluated. Therapeutic outcome was judged at day 56 after the last sclerosing therapy. Blood ethanol levels of ethanol were measured after each infusion. Local and systemic adverse events were recorded. RESULTS: Seventy-five (75) patients (age 4-46 y, mean 26 y) were treated in 172 sessions. Compared to no treatment, ethanol gel showed a complete cure rate of about 15% per session (p<0.00001). At the end of the last session, therapeutic outcome was complete (score 2) and partial (score 1) in 28 (37%) and 42 patients (56%), respectively, whereas treatment failure (score 0) was observed in 5 patients (7%). The plasmatic ethanol levels were very low (mean±SEM 0.03±0.06 g L(-1)), with only one patient above the legal 0.5 g L(-1) intoxication limit (0.6 g L(-1)). Forty-six (46) product-related adverse events (all local, none systemic) were reported. They included temporary mild isolated pain (N=21), inflammatory reactions (N=4), and local complications (7 skin necroses, 7 compressive neuropathies, 4 product leakage/fistula, 2 intralesional fibrous or granulomatous tissue, 1 dense node; 12.2% of the infusions). All local complications resolved spontaneously, except for 2 skin necroses requesting surgical paring. CONCLUSION: Ethanol gel is an embosclerosing substance that provides high efficiency and improves safety of ethanol in the treatment of VM lesions.

Quality of life in patients with uraemic xerosis and pruritus.

A total of 334 end-stage renal disease patients with moderate-to-severe uraemic xerosis were surveyed for quality of life assessment, using the generic Short-Form (SF-12) scale and the Dermatology Life Quality Index (DLQI). In parallel, the intensity of xerosis at four sites (the two lower legs, chest, forearm without arterio-venous shunt) was assessed, using a five-point lesional intensity score. Pruritus was auto-assessed by the patients, using a 100-mm visual analogue scale. Uraemic xerosis patients had a marked deterioration in the Physical Component Summary of SF-12 (mean ± SD: 34.92 ± 9.98) and DLQI (5.06 ± 4.73). Younger age (r = -0.20), xerosis intensity (r = 0.14), and the presence of pruritus (p < 0.0001) and its intensity (r = 0.50) were shown to be significant worsening factors of DLQI. Because a low, but significant, correlation between the intensity of xerosis and pruritus was also demonstrated (r = 0.18), the direct contribution of age, xerosis and pruritus on DLQI was analysed in a multiple linear regression model. Age and pruritus intensity, but not xerosis intensity, were found to be independent contributors to DLQI deterioration (p < 0.0005). On the other hand, uraemic xerosis without associated pruritus still resulted in DLQI alteration (3.24 ± 3.99). It was concluded that young age and intensity of uraemic pruritus compromise quality of life in uraemic xerosis patients. Some characteristics of uraemic xerosis other than xerosis intensity may also be involved in quality of life alteration.

Randomized, double-blind study with glycerol and paraffin in uremic xerosis.

BACKGROUND AND OBJECTIVES: Uremic xerosis is a bothersome condition that is poorly responsive to moisturizing and emollient therapy. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A randomized, double-blind, intraindividual (left versus right comparison), multicentric clinical study was performed on 100 patients with moderate to severe uremic xerosis for 7 days, during which the patients applied twice daily an emulsion combining glycerol and paraffin (test product) on one allocated lower leg, and the emulsion alone (comparator) on the other lower leg. This was followed by an open-labeled use of the test product on all of the xerotic areas for 49 days. The main efficacy parameter was treatment response on each lower leg, as defined by a reduction from baseline of at least two grades in a five-point clinical score on day 7. RESULTS: Among the 99 patients analyzed, the test product was highly effective with a treatment response in 72 patients (73%), whereas 44 patients (44%) responded to the comparator (P<0.0001, intergroup analysis). This was associated with an objective reduction in the density and thickness of the scales on day 7 (P<0.0001 compared with the comparator) and a substantial improvement of the uremic pruritus (75%) and quality of life of the patients at study end (P<0.001, intragroup analysis). The test product was very well tolerated, with product-related local intolerance (exacerbated pruritus, local burning, or erythema) occurring in only five patients (5%). CONCLUSIONS: Uremic xerosis can be managed successfully when an appropriate emollient therapy is used.

Photoprotective effects of a broad-spectrum sunscreen in ultraviolet-induced cutaneous lupus erythematosus: a randomized, vehicle-controlled, double-blind study.

OBJECTIVE: We sought to assess if the exclusive use of a broad-spectrum sunscreen can prevent skin lesions in patients with different subtypes of cutaneous lupus erythematosus (CLE) induced by ultraviolet (UV) irradiation under standardized conditions. METHODS: A total of 25 patients with a medical history of photosensitive CLE were included in this monocentric, randomized, vehicle-controlled, double-blind, intraindividual study. The test product and its vehicle were applied 15 minutes before UVA and UVB irradiation of uninvolved skin areas on the upper aspect of the back in a random order, and standardized phototesting was performed daily for 3 consecutive days. RESULTS: Characteristic skin lesions were induced by UVA and UVB irradiation in 16 patients with CLE in the untreated area, and 14 patients showed a positive test result in the vehicle-treated area. In contrast, no eruptions compatible with CLE were observed in the sunscreen-treated area in any of the 25 patients. This resulted in significant differences (P < .001) between UV-irradiated sunscreen-treated versus vehicle-treated areas, and between UV-irradiated sunscreen-treated versus untreated areas. Furthermore, a significant difference (P < .05) was observed concerning the age of disease onset and the patient history of photosensitivity. Patients who were younger than 40 years at onset of CLE reported photosensitivity significantly more often than patients with a higher age of disease onset. None of the patients showed any adverse events from application of the test product or the vehicle. LIMITATIONS: Data resulting from standardized experimental phototesting might not be transferable to a clinical setting. CONCLUSION: These results indicate clearly that the use of a highly protective broad-spectrum sunscreen can prevent skin lesions in photosensitive patients with different subtypes of CLE.