A prospective multicenter study of the efficacy and tolerability of cryopreserved allogenic human keratinocytes to treat venous leg ulcers.

Allogeneic human keratinocyte cultures have been used to treat burn wounds, donor sites, and chronic skin ulcers with some success. Cryopreservation of these cultures allows for the production of large standardized batches that are readily available for use. The aim of the study presented in this report was to study effects of cryopreserved cultured allogenic human keratinocytes (CryoCeal) on chronic lower extremity wounds. Parameters were measured to study efficacy, tolerability, pain associated with chronic wounds, and quality of life of patients. Twenty-seven patients with hard-to-heal venous leg ulcers received a maximum of 9 applications of CryoCeal in a prospective, uncontrolled multicenter study lasting 48 weeks. Eleven out of 27 patients (41%; 95% CI: 22%-61%) had complete wound closure within 24 weeks (1 week). The time required for complete wound closure in these 11 patients ranged from 4.1 to 24.9 weeks. Only 1 patient had recurrence of the ulcer at 48 weeks. Local (wound) pain scores decreased from a mean of 2.5 at baseline to 0.9 at week 24. Fifty percent of the patients attained a pain score of 0 after 12 weeks and remained stable at this score until the end of the study. Overall, the patient quality of life was better at week 24, compared to baseline values. The treatment was well tolerated, and wound infection was the most frequently occurring adverse event.

The combination of calcipotriol and methotrexate compared with methotrexate and vehicle in psoriasis: results of a multicentre placebo-controlled randomized trial.

BACKGROUND: A multicentre, randomized, double-blind, vehicle-controlled, parallel-group study was carried out to study the effect of the addition of calcipotriol ointment to methotrexate (MTX) therapy in patients with psoriasis vulgaris. OBJECTIVES: To investigate whether the addition of calcipotriol to treatment with MTX has an MTX-sparing effect, and whether the combination of treatments is safe. Additionally, to compare the effect of calcipotriol or vehicle on the duration of the relapse-free interval after cessation of MTX. METHODS: Patients on maintenance therapy with MTX with controlled psoriasis were selected. The study was divided into three phases: (i) an MTX-free phase with double-blind treatment with either calcipotriol ointment or vehicle; (ii) an MTX titration phase with open MTX treatment and additional double-blind treatment with either calcipotriol or vehicle until target response; and (iii) follow-up phase: in a group of 97 patients, psoriasis was assessed using the modified psoriasis severity score, patients' assessment and safety parameters were monitored as well. RESULTS: The combined use of calcipotriol with MTX resulted in an MTX-sparing effect of 3.4 mg week-1 (phase (II) and 2.6 mg week-1 (phase I and II taken together), while still maintaining efficacy. Calcipotriol treatment increased the time to relapse of psoriasis following discontinuation of MTX: 113 days vs. 35 days. A decrease in aspartate aminotransferase and alanine aminotransferase was seen during the study of 8% (calcipotriol) and 12% (vehicle). CONCLUSIONS: The combination of calcipotriol and MTX was safe and well tolerated. The combination resulted in lower cumulative dosages of MTX compared with MTX and vehicle. Therefore the risk of side-effects is substantially decreased.

Value of standard laboratory tests for the early recognition of group A beta-hemolytic streptococcal necrotizing fasciitis.

The laboratory data for 17 patients with group A beta-hemolytic streptococcal necrotizing fasciitis (GAS NF) were compared with data for 145 patients hospitalized for cellulitis during the same period. Admission values of C-reactive protein and creatine kinase were higher for patients in the group with GAS NF than for patients in the group with cellulitis (P<.001), suggesting that standard laboratory tests may be useful for the early differential diagnosis of GAS NF and cellulitis.

Calcipotriol cream in the morning and ointment in the evening: a novel regimen to improve compliance.

BACKGROUND: Calcipotriol ointment and calcipotriol cream have both been shown to be effective in the treatment of psoriasis. AIM: To find out the patient compliance, efficacy and tolerance to a regimen of a calcipotriol cream application in the morning and a calcipotriol ointment application in the evening. METHODS: In order to obtain data relevant to daily practice, information was obtained from patients and dermatologists on the treatment of psoriasis with a combination of calcipotriol ointment and calcipotriol cream. In total, three assessments were carried out: at the beginning, after 3 weeks and after 8 weeks. The first assessment comprised general demographics, localization of the lesions, the percentage body surface involved, and details on other antipsoriatic medications. The second and third assessments were an evaluation of compliance and efficacy in comparison with calcipotriol ointment monotherapy, provided that the patients had experience with this treatment. In total, 976 patients were included by 170 dermatologists in The Netherlands and Belgium. RESULTS: Compliance with the combined use of calcipotriol cream in the morning and calcipotriol ointment in the evening was optimal in 60-70% of the patients. The highest compliance was shown at the second visit but dropped at the third visit. Those patients with previous experience of calcipotriol ointment indicated that the calcipotriol cream/ointment regimen was a better principle. Response to the calcipotriol cream/ointment regimen was considered good in 67-76% of the patients. CONCLUSION: The present study indicates that the combined use of calcipotriol cream in the morning and ointment in the evening is useful as a principle for mild to severe psoriasis. A total of 67-68% of the patients stated that this regimen was the most preferred topical treatment of psoriasis.

Halomethasone (C 48.401-Ba) for the topical treatment of common dermatoses.

C 48.401-Ba cream, containing 0.05% halomethasone was compared in a double-blind between-patients trial with a cream containing 0.1% betamethasone valerate in forty-eight patients suffering from atopic dermatitis and in thirty-nine patients suffering from seborrhoeic dermatitis. A similar comparison was made with ointments containing the same concentration of active ingredient in forty-six patients suffering from atopic dermatitis. Both ointments were also compared in a within-patient double-blind trial in thirty patients suffering from psoriasis. The analysis of the results showed that for the treatment of the above-mentioned dermatoses, both drugs, the cream as well as the ointment, are equally effective and well tolerated.