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Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial.

Br J Dermatol. 2008 Feb 21;

Authors: Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Holló P, Cambazard F, Lahfa M, Elsner P, Nyberg F, Svensson A, Brown TC, Harsch M, Maares J

Background Patients with severe chronic hand eczema (CHE) refractory to topical corticosteroids currently have limited treatment options suited for chronic use, and few controlled clinical studies have investigated new therapies in this setting. Objectives To assess the efficacy and safety of oral alitretinoin (9-cis retinoic acid) taken at 10 mg or 30 mg once daily for up to 24 weeks, compared with placebo control, in the treatment of severe CHE refractory to topical corticosteroids. Methods A randomized, double-blind, placebo-controlled, prospective, multicentre trial was conducted in 111 dermatology outpatient clinics in Europe and Canada. A total of 1032 patients with severe refractory CHE were randomized in a 1 : 2 : 2 ratio to placebo, or 10 mg or 30 mg of oral alitretinoin once daily for up to 24 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for relapse for 24 weeks after the end of therapy. The primary efficacy parameter was Physician Global Assessment of overall CHE severity, with response defined as clear or almost clear hands. Results Responses, defined as clear or almost clear hands, were achieved in up to 48% of patients treated with alitretinoin, compared with 17% for placebo (P < 0.001), with up to 75% median reduction in disease signs and symptoms. Treatment was well tolerated, with dose-dependent adverse effects comprising headache, mucocutaneous events, hyperlipidaemia, and decreased free thyroxine and thyroid-stimulating hormone. The median time to relapse, defined as recurrence of 75% of initial signs and symptoms, was 5.5-6.2 months in the absence of anti-eczema medication. Conclusions Alitretinoin given at well-tolerated doses induced clearing of CHE in a substantial proportion of patients with severe disease refractory to standard therapy.

PMID: 18294310 [PubMed - as supplied by publisher]

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Reduction of relapses of atopic dermatitis with methylprednisolone aceponate cream twice weekly in addition to maintenance treatment with emollient: a multicentre, randomized, double-blind, controlled study.

Br J Dermatol. 2008 Feb 16;

Authors: Peserico A, Städtler G, Sebastian M, Fernandez RS, Vick K, Bieber T

Background The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of active AD, but their long-term efficacy and potential to reduce or prevent relapses have only partially been addressed. Objectives To investigate long-term management (16 weeks) of AD with methylprednisolone aceponate (MPA) 0.1% cream twice weekly in addition to an emollient (Advabase((R))) after stabilization of an acute severe or very severe flare of AD with MPA cream. Methods Patients >/= 12 years of age with a >/= 2-year history of moderate to severe AD were eligible for this multicentre, randomized, double-blind, controlled study if they presented with an acute flare of severe or very severe AD [Investigator’s Global Assessment (IGA) score >/= 4]. After successful treatment of the flare in an acute phase (AP), patients received either MPA twice weekly plus emollient or emollient alone over a 16-week maintenance phase (MP). The primary study endpoint was time to relapse of AD. Secondary endpoints included relapse rate and disease status, the patient’s assessment of intensity of itch, the Eczema Area and Severity Index, the IGA score, affected body surface area, Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI), patient’s and investigator’s global assessment of response and patient’s assessment of quality of sleep. Results Two hundred and forty-nine patients entered the AP and 221 continued into the MP. Time to relapse was longer in the MPA group than in the emollient group. The probability of remaining free from relapse after 16 weeks was 87.1% in the MPA group compared with 65.8% for the emollient. Patients treated with MPA twice weekly had a 3.5-fold lower risk of experiencing a relapse than patients treated with emollient alone (hazard ratio 3.5, 95% confidence interval 1.9-6.4; P < 0.0001). MPA was also superior to emollient for all other efficacy endpoints. Therapy with both treatments was well tolerated. Conclusions MPA twice weekly plus an emollient provides an effective maintenance treatment regimen to control AD. Once stabilized, treatment with MPA significantly reduces the risk of relapse and the intensity of itching, and improves the overall patient status.

PMID: 18284403 [PubMed - as supplied by publisher]

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The efficacy of ‘0.05% Clobetasol + 2.5% zinc sulphate’ cream vs. ‘0.05% Clobetasol alone’ cream in the treatment of the chronic hand eczema: a double-blind study.

J Eur Acad Dermatol Venereol. 2008 Feb 12;

Authors: Faghihi G, Iraji F, Shahingohar A, Saidat A

Background Many therapeutic modalities have been suggested for treatment of the chronic hand eczema. Despite good immediate efficacy of some of these treatments, there is high recurrence of the dermatitis following cessation of the treatment. Aim Regarding the beneficial effects of the zinc sulfate on the skin, we designed a double blind study to evaluate the efficacy of the ‘0.05% Clobetasol + 2.5% zinc sulphate’ cream versus ‘0.05% Clobetasol alone’ cream in the treatment of the chronic hand eczema. Subjects and Methods This study was a double-blind, right to left, prospective, clinical trial. In total, 47 patients with chronic hand eczema admitted to dermatology center of Isfahan University of Medical Sciences were selected and their right hand or left hand were selected at random to be treated with either the ‘0.05% Clobetasol + 2.5% zinc sulphate’ cream or ‘0.05% Clobetasol alone’ cream twice daily for 2 weeks. All of the patients were treated for 2 weeks and were followed up at weeks 2, 4, 6 and 8 after starting the treatment. For determining the severity of chronic hand eczema, we assessed and scored 4 different characteristics of the lesions including redness; scaling; lichenification and pruritus. The data were analyzed using SPSS program (release 13) and statistical tests including Mann-Whitney test. Results Overall, 47 patients (94 samples) were evaluated. All of these patients had similar and symmetrical lesions on their right and left hands. Out of them, 35 patients were females and 12 patients were male. In all of the evaluated characterisitics, the ‘0.05% Clobetasol + 2.5% zinc sulphate’ cream was more effective than ‘0.05% Clobetasol alone’ cream (P < 0.05). The recurrence rate of eczema was significantly lower in the group treated with this combination treatment (P < 0.05). Conclusion With regard to the encouraging results of the combination treatment with Clobetasol + zinc sulphate, we suggest that in a more extensive clinical trial, the efficacy of this treatment against chronic hand dermatitis be evaluated. In addition, evaluation of this combination therapy against other inflammatory dermatosis seems to be logical.

PMID: 18284511 [PubMed - as supplied by publisher]

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Molecular analysis of Malassezia microflora in seborrheic dermatitis patients: comparison with other diseases and healthy subjects.

J Invest Dermatol. 2008 Feb;128(2):345-51

Authors: Tajima M, Sugita T, Nishikawa A, Tsuboi R

Malassezia species colonize the skin of normal and various pathological conditions including pityriasis versicolor (PV), seborrhoeic dermatitis (SD) and atopic dermatitis (AD). To elucidate the pathogenic role of Malassezia species in SD, Malassezia microflora of 31 Japanese SD patients was analyzed using a PCR-based, culture-independent method. Nested PCR assay using the primers in the rRNA gene indicated that the major Malassezia species in SD were M. globosa and M. restricta, found in 93 and 74% of the patients, respectively. The detection rate and number of each species varied similarly in SD, PV and healthy subjects (HSs), whereas AD showed higher values. Real-time PCR assay showed that the lesional skin harbored approximately three times the population of genus Malassezia found in nonlesional skin (P<0.05), and that M. restricta is a significantly more common species than M. globosa in SD (P<0.005). Genotypic analysis of the rRNA gene showed that the M. globosa and M. restricta from SD patients fell into specific clusters, and could be distinguished from those collected from HSs, but not from those colleted from AD patients. Our results indicate that certain strains of M. restricta occur in the lesional skin of SD patients.

PMID: 17671514 [PubMed - indexed for MEDLINE]

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Transglutaminase autoantibodies in dermatitis herpetiformis and celiac sprue.

J Invest Dermatol. 2008 Feb;128(2):332-5

Authors: Marietta EV, Camilleri MJ, Castro LA, Krause PK, Pittelkow MR, Murray JA

Dermatitis herpetiformis (DH) is an autoimmune blistering skin disorder that is associated with intestinal gluten sensitivity. Epidermal transglutaminase (TGe) and closely related tissue transglutaminase (tTG) are considered to be autoantigens in DH, because a majority of DH patients have IgA specific for TGe and for tTG. It is unknown where and how these autoantigen-specific IgAs are generated in DH. Results reported in this paper on nine DH patients on a gluten containing diet demonstrate that the levels of circulating anti-tTG IgA and anti-TGe IgA in DH are correlated with each other and that both appear to be correlated with the degree (extent) of enteropathy. An analysis of 15 untreated celiac sprue (CS) patients demonstrated that approximately 33% of CS patients had elevated levels of anti-TGe IgA. These results would indicate that intestinal damage is associated with the production of anti-tTG IgA and anti-TGe IgA in DH patients.

PMID: 17762854 [PubMed - indexed for MEDLINE]

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Further exploring the brain-skin connection: stress worsens dermatitis via substance P-dependent neurogenic inflammation in mice.

J Invest Dermatol. 2008 Feb;128(2):434-46

Authors: Pavlovic S, Daniltchenko M, Tobin DJ, Hagen E, Hunt SP, Klapp BF, Arck PC, Peters EM

A neurogenic component in atopy and allergy is evident and potentially of great pathogenic relevance. Stress was recently shown to activate elements of this component and is vividly discussed as a cause of exacerbation. However, to date, scientific proof of stress-induced neuronal plasticity and neuro-immune interaction in atopy or allergy remains lacking. Here we show early evidence that exposure to sound stress and atopic dermatitis-like allergic dermatitis (AD) equipotently raise the number of cutaneous nerve fibers containing the prototypic stress neuropeptide substance P (SP) in mice. Stress increases AD readout parameters by at least 30% (eosinophil infiltration, vascular cell adhesion molecule-positive blood vessels, epidermal thickness). This dramatic pathologic exacerbation is associated with increased neurogenic inflammation (degranulated mast cells; interstitial neuropeptidergic dense core granules, mast cell apoptosis, endothelial gaping). Key features of AD exacerbation could not be induced in mice lacking the neurokinin-1 SP receptor (NK1). Interestingly, stress had no significant additional effect on CD4+ cell number, but shifted the cytokine profile toward TH2 in skin. Thus, we conclude that stress primarily exacerbates AD via SP-dependent cutaneous neurogenic inflammation and subsequent local cytokine shifting and should be considered as a therapeutic target, while it offers a convincing pathogenic explanation to affected patients and their frustrated physicians alike.

PMID: 17914449 [PubMed - indexed for MEDLINE]

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Hypersensitivity to aeroallergens in adult patients with atopic dermatitis develops due to the different immunological mechanisms.

Eur J Dermatol. 2007 Nov-Dec;17(6):520-4

Authors: Samochocki Z, Owczarek W, Rujna P, Raczka A

Atopic dermatitis (AD) is a disease with a complex pathomechanism, it is very difficult to establish the exact factors which can either trigger or exacerbate the disease. Knowledge of the mechanisms involved in AD development can be increased by, among others, applying new diagnostic tests and careful assessment of the results obtained. The aim of this study was to determine the allergic mechanisms of hypersensitivity to selected aeroallergens in patients with AD. The study comprised 109 AD patients. In all the patients the total IgE level was measured and atopy patch tests and skin prick tests were performed. We also assessed the presence of specific IgE against house dust mite, birch-tree, mixed grass pollen and cat dander. The highest incidence of positive results was found for house dust mite allergens, irrespective of the test employed. Analysing hypersensitivity to all the examined allergens we revealed the presence of allergic mechanisms in 85.3% of the patients. In 30.2% of the examined individuals we proved a type I immunological response, in 45.9% — both types I and IV in 9.2% — only type IV in one patient. In 14.7% of the patients the results of all the tests performed were negative. Analysing hypersensitivity to particular aeroallergens, negative test results to house dust mite were observed in 25.8% of the patients. The percentage of positive results for birch pollen, grass pollen and cat dander were 45.0, 44.1 and 53.2, respectively. Analysis of the results showed that allergic reactions to the same aeroallergens may develop via different mechanisms. We also revealed that the coexistence of various mechanisms involved in the development of hypersensitivity to a particular aeroallergen may occur in individual patients.

PMID: 17951133 [PubMed - indexed for MEDLINE]

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Stasis dermatitis-like leukaemic infiltration in a patient with myelodysplastic syndrome.

Clin Exp Dermatol. 2008 Feb 2;

Authors: Papadavid E, Panayiotides I, Katoulis A, Pappa V, Dervenoulas I, Stavrianeas N

We report a case of leukaemia cutis presenting as stasis dermatitis-like eruption in a patient with myelodysplastic syndrome progressing to acute myelogenic leukaemia.

PMID: 18261141 [PubMed - as supplied by publisher]

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Diffuse dermatitis: An unexpected initial presentation of cystic fibrosis.

J Am Acad Dermatol. 2008 Feb;58(2 Suppl):S1-4

Authors: Lovett A, Kokta V, Maari C

Cystic fibrosis is an autosomal recessive disease that typically presents with pulmonary symptoms. Diffuse rash related to protein energy malnutrition can rarely be a presenting sign of cystic fibrosis in infancy. We report such a case and relate the difficulties of establishing a diagnosis. We also discuss possible pathophysiological mechanisms, histopathology, prognosis, and treatment.

PMID: 18191689 [PubMed - indexed for MEDLINE]

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A retrospective case series review of the peroxisome proliferator-activated receptor ligand rosiglitazone in the treatment of atopic dermatitis.

Arch Dermatol. 2008 Jan;144(1):84-8

Authors: Behshad R, Cooper KD, Korman NJ

BACKGROUND: Peroxisome proliferator-activated receptors (PPARs) are nuclear hormone receptors that are expressed in a variety of cells, including keratinocytes and cells of the immune system. The gamma subtype, activated by the antidiabetic thiazolidinediones, was originally identified as a regulator of adipogenesis and glucose homeostasis. Recent data, however, have linked PPAR-gamma to several genes involved in inflammation. Among others, these pathways reduce certain inflammatory mediators in the skin and regulate epidermal barrier homeostasis, alterations of which contribute to the inflammation associated with atopic dermatitis (AD). To our knowledge, the addition of rosiglitazone maleate to the standard treatment of AD has not been evaluated. OBSERVATIONS: Severe adverse events were not observed, although 1 patient experienced weight gain. All patients responded to rosiglitazone therapy with decreased total body surface area involvement, severity of lesions, and number of flares. CONCLUSIONS: Rosiglitazone, a drug that has an excellent safety profile, may offer a well tolerated systemic treatment option for AD. However, its role should be further assessed in controlled trials to establish its efficacy and safety in this disease.

PMID: 18209172 [PubMed - indexed for MEDLINE]

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