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    Journal of the American Academy of Dermatology 11/2014; 71(5):1008–1011. · 4.91 Impact Factor
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    ABSTRACT: Background Psoriasis patients over 65 years-old (elderly) constitute a growing group, underrepresented in clinical trials, and likely to be more prone to adverse events.Objective To describe safety of systemic psoriasis therapy in patients over 65 years-old compared to younger patients.Methods Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were grouped in elderly (≥ 65 years old) and younger patients. Rates of adverse events were described by severity and type, and the risks compared in both groups, taking into account exposure to classic or biologic drugs, using Cox regression.Results175 (9.8%) of 1793 patients were elderly. Overall risk of adverse events was not higher in elderly (drug group adjusted HR 1.09 (95%CI: 0.93-1.3)). Serious adverse events were more common in elderly (drug group adjusted HR 3.2 (95%CI: 2.0-5.1)). Age adjusted HR of all adverse events was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR 0.7 (95%CI: 0.6-0.7)). Age did not seem to modify the effect of therapy (biologic vs. classic) in the risk of adverse events (likelihood ratio test for interaction, p = 0.12 for all adverse events, p = 0-09 for serious adverse events).Conclusions Serious adverse events are more common in elderly patients, although they may be related to other variants that are associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk of adverse events in the whole group. We found no differences in this association between young and elderly. These results are reassuring, although uncontrolled confounding could not be excluded as an explanation for these findings, and the power of the study to detect differences was low.
    Journal of the European Academy of Dermatology and Venereology 09/2014; · 2.69 Impact Factor
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    ABSTRACT: Hidradenitis suppurativa (HS) or acne inversa is a chronic inflammatory process that affects the apocrine glands of the skin folds. Recent histological investigations suggests that HS involving an entire hair follicle with follicular hyperkeratosis in early stages. HS has a prevalence of approximately between 1 and 2% and most often affects obese patients and smokers.1-3 HS is characterised by abscesses and nodules and often involves fistulas and scarring. Fistulas are extremely uncomfortable and cause recurrent infections. Thus, HS interferes severely in the quality of life of patients and the treatment options have limited efficacy. Relapses are frequent when fistulas play a fundamental role.This article is protected by copyright. All rights reserved.
    British Journal of Dermatology 09/2014; · 3.76 Impact Factor
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    ABSTRACT: Es poco conocida la disponibilidad y el empleo de la hospitalización dermatológica, así como su evolución temporal y el porcentaje de enfermedades potencialmente dermatológicas que ingresan en otros servicios. Los objetivos de nuestro estudio son describir los ingresos dermatológicos en el Sistema Nacional de Salud en España entre los años 2005 y 2010 y los ingresos por proceso patológico susceptible de ser ingresado en dermatología en el SNS en el año 2010. Los datos del estudio han sido obtenidos del registro de altas de hospitalización y atención ambulatoria especializada del Ministerio de Sanidad, Servicios Sociales e Igualdad (conjunto mínimo básico de datos [CMBD]). En los años incluidos en nuestro estudio no observamos descenso en las tasas de ingresos médicos; sı´ descienden los ingresos quirúrgicos. Existe gran variabilidad en la actividad de ingresos dermatológicos en las distintas provincias en la hospitalización dermatológica y la mayoría de las enfermedades dermatológicas que ingresan no lo hacen en servicios de dermatología. Little is known about the availability and use of dermatological hospitalization, or its temporal trends and the percentage of potentially dermatological diseases treated by non-dermatology departments. The objectives of our study were to describe the dermatological admissions rate in Spain between 2005 and 2010, as well as the hospitalization rate by diseases suitable for treatment in a dermatology department in the publicly-funded health system in 2010. Data were obtained from Spain’s Ministry of Health, Social Services and Equality (Minimum Data Set [MDS]) book of records for hospitalizations and outpatient specialist care. In the years covered by our study, surgical admissions decreased but medical admissions were unchanged. There was wide variability among the Spanish provinces in their rates of dermatology-related hospitalizations. Most patients with dermatological diseases were admitted to services other than the dermatology department.
    Piel 05/2014;
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    ABSTRACT: Background Biobadaderm is the Spanish registry of psoriasis patients receiving systemic treatment in clinical practice.Objective To compare the safety of biologics and classic systemic treatment.Methods Prospective cohort of patients receiving biologics and classic systemic therapies between 2008 and 2013 in 12 hospitals are included. We registered demographic data, diagnoses, comorbidities, treatments and adverse events (AE). We obtained raw relative risks (RR) for specific AE. Multivariate analysis consisted of Cox models adjusting for age, gender, chronic hepatic disease and previous cancer.ResultsA total of 1030 patients received biologics (2061 AE in 3681 person-years), 926 patients classic systemic drugs (1015 AE in 1517 person-years). Ninety-three per cent of AE in both groups were non-serious, 6% serious and 0.003% fatal. The age- and gender-adjusted hazard ratio of AE was lower in the biologics group [hazard ratio 0.6 (95% CI: 0.5–0.7)].We found no differences in rates of serious and mortal AE. Some system organ class AE rates differed between both groups. As limitations: Prescription bias might affect the incidence of AE in both groups. Association of drug and AE was based on timing: associations might not be causal.Conclusion Patients receiving biologics had lower risk of AE. We did not find differences in the risk of serious or fatal AE.
    Journal of the European Academy of Dermatology and Venereology 03/2014; · 2.69 Impact Factor
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    ABSTRACT: Systematic reviews -the most comprehensive type of literature review- should be taken into account before a clinical trial or a narrative review on a topic is undertaken. The objective of this study was to describe the use of systematic reviews in clinical trials and narrative reviews in dermatology. This was a descriptive cross-sectional study. We selected randomized clinical trials and narrative reviews from the dermatological clinical research journals identified as most important (according to impact factor) and from Actas Dermosifiliográficas, and studied the bibliographies to ascertain whether the authors made reference to existing systematic reviews and Cochrane reviews. Of the 72 clinical trials for which a systematic review was available, 24 (33.3%) cited at least 1 review; reference was made to relevant Cochrane reviews in 15.6% of cases and to non-Cochrane reviews in 32%. In the case of the 24 narrative reviews for which a review was available, 10 (41.7%) cited at least 1 review; Cochrane reviews were cited in 20% and non-Cochrane reviews in 35.3%.In the case of Actas Dermosifiliográficas, very few clinical trials were found and the findings for narrative review articles were similar to those observed for the other journals. Systematic reviews are not often taken into account by the authors of clinical trials and narrative reviews and this may lead to redundant studies and publications. Authors appear to use Cochrane reviews even less than non-Cochrane reviews and are therefore ignoring one of the main sources of available evidence.
    Actas Dermo-Sifiliográficas 01/2014;
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    ABSTRACT: Introduction and objectives Systematic reviews —the most comprehensive type of literature review— should be taken into account before a clinical trial or a narrative review on a topic is undertaken. The objective of this study was to describe the use of systematic reviews in clinical trials and narrative reviews in dermatology. Material and methods This was a descriptive cross-sectional study. We selected randomized clinical trials and narrative reviews from the dermatological clinical research journals identified as most important (according to impact factor) and from Actas Dermosifiliográficas, and studied the bibliographies to ascertain whether the authors made reference to existing systematic reviews and Cochrane reviews. Results Of the 72 clinical trials for which a systematic review was available, 24 (33.3%) cited at least 1 review; reference was made to relevant Cochrane reviews in 15.6% of cases and to non-Cochrane reviews in 32%. In the case of the 24 narrative reviews for which a review was available, 10 (41.7%) cited at least 1 review; Cochrane reviews were cited in 20% and non-Cochrane reviews in 35.3%.In the case of Actas Dermosifiliográficas, very few clinical trials were found and the findings for narrative review articles were similar to those observed for the other journals. Conclusions Systematic reviews are not often taken into account by the authors of clinical trials and narrative reviews and this may lead to redundant studies and publications. Authors appear to use Cochrane reviews even less than non-Cochrane reviews and are therefore ignoring one of the main sources of available evidence.
    Actas Dermo-Sifiliográficas 01/2014;
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    P. Davila-Seijo, A. Batalla, I. Garcia-Doval
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    ABSTRACT: Introducción y objetivos Las revisiones sistemáticas son una de las fuentes más importantes de Medicina basada en la evidencia. No obstante, existe una impresión de que estas revisiones rara vez aportan resultados con evidencia suficiente para cambiar nuestra práctica. El objetivo de este trabajo es determinar el porcentaje de revisiones publicadas por el Cochrane Skin Group (Grupo Cochrane de Piel) con resultados útiles para guiar nuestras decisiones clínicas. Material y métodos Se ha realizado un análisis bibliométrico de las revisiones sistemáticas realizadas por el Cochrane Skin Group y publicadas hasta el 16 de agosto de 2012. Se obtuvieron un total de 55 revisiones, las cuales fueron analizadas y clasificadas de forma independiente por 2 investigadores en: 0) no existe evidencia suficiente para apoyar o rechazar ninguna intervención; 1) no existe evidencia suficiente para rechazar o apoyar una intervención pero sí existe suficiente evidencia para hacer recomendaciones o sugerencias; y 2) existe una fuerte evidencia para apoyar o rechazar una intervención. Resultados Del total de las revisiones publicadas por el Cochrane Skin Group el 25,5% (14/55) no mostraban evidencia suficiente en ninguna de las intervenciones estudiadas para sustentar su rechazo o aprobación. Un 29,1% (16/55) obtuvo resultados con una fuerte evidencia a favor o en contra de alguna de las intervenciones estudiadas y el 45,5% (25/55) mostraba evidencia suficiente, aunque no fuerte, para hacer sugerencias o recomendaciones. Conclusiones La mayoría de las revisiones sistemáticas del Cochrane Skin Group aportan información útil para mejorar nuestra actividad clínica. Los clínicos deberían leerlas y compararlas con su práctica actual.
    Actas Dermo-Sifiliográficas 10/2013; 104(8):679–684.
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    P Davila-Seijo, A Batalla, I Garcia-Doval
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    ABSTRACT: The ichthyoses comprise a group of inherited disorders of keratinization. Because of the need for lifelong treatment, it is important that therapies are beneficial, safe, and well tolerated. We sought to review the evidence on existing treatments for the congenital ichthyoses, excluding ichthyosis vulgaris. We undertook a systematic review using the methodology of the Cochrane Collaboration. Articles published in MEDLINE, EMBASE, and CENTRAL and registered clinical trials were screened. Randomized controlled trials involving patients with the inherited ichthyoses, either syndromic or nonsyndromic but excluding ichthyosis vulgaris, were considered. Six trials met the inclusion criteria. Topical treatments including 5% urea, 20% propylene glycol alone or in combination with 5% lactic acid, calcipotriol ointment, and liarozole 5% cream showed therapeutic benefit. Oral liarozole, a retinoic acid metabolism blocking agent, showed no advantage over oral acitretin. Most studies were performed on a small sample of patients and lacked methodological and reporting quality. The small number of trials and the nearly constant positive results make publication bias likely. The absence of standardization of outcome measures precluded the comparison of studies. Topical treatments including emollients, calcipotriol ointment, and liarozole cream seem to have therapeutic benefit and a good safety profile, although the use of topical calcipotriol is limited by a maximum weekly dose of 100 g. The advantage of oral liarozole over acitretin is uncertain. Multicenter trials comparing oral and topical interventions and evaluation of long-term outcomes are needed.
    Journal of the American Academy of Dermatology 07/2013; · 4.91 Impact Factor
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    ABSTRACT: There are few data on the prevalence of obesity in the general psoriasis population and on the real impact of obesity on the management of psoriasis patients in the clinical setting. To evaluate the prevalence of overweight and obesity in patients with moderate-to-severe psoriasis compared to the general population and to assess the relationship between Body Mass Index (BMI) and the risk of discontinuing treatment. Patients registered on Biobadaderm, a prospective registry, were grouped according the different categories of BMI and compared to the general Spanish population. Drug survival was analysed considering only drug withdrawal due to lack of effectiveness, remission and adverse events. A total of 1162 moderate-to-severe psoriasis patients on systemic conventional or biological treatment were recruited. The prevalence of obesity was found to be significantly higher in psoriasis patients than in the general Spanish population (P < 0.001). In multivariate analysis a 5-unit increase in BMI, similar to a change in BMI category from normal weight to overweight and from overweight to obesity, was associated with a 12% increased risk of discontinuing therapy due to lack of effectiveness (HR 1.12, 95% CI: 1.01-1.24) and with a 17% increased risk of having an adverse event (HR 1.17, 95% CI: 1.02-1.36), both independently of the drug used. Patients with moderate-to-severe psoriasis had a higher prevalence of obesity than the general population. Increased BMI was associated with an increased risk of treatment discontinuation due to lack of effectiveness and a higher risk of adverse events.
    Journal of the European Academy of Dermatology and Venereology 07/2013; · 2.69 Impact Factor
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    ABSTRACT: Dystrophic epidermolysis bullosa (DEB) is a rare disease that represents a heavy burden for both the patient and the health care system. There are currently no data on the prevalence of DEB in Spain. To determine the prevalence of DEB in Spain. We used data from 3 incomplete population-based sources (hospital dermatology departments, diagnostic laboratories performing antigenic mapping, genetic testing or both, and the Spanish Association of Epidermolysis Bullosa Patients [DEBRA]) and combined them using the 3-source capture-recapture methodology. We identified 152 living DEB patients. The estimated prevalence of DEB was 6.0 cases per million (95% CI, 4.2-11.8) in adults and 15.3 (95% CI, 10.4-40.8) in children under 18 years of age. The data indicated that 77% of the patients were not being followed up in specialized centers of reference; 65% had not had a genetic diagnosis, and 76% were not members of DEBRA. The prevalence of DEB in Spain is 6.0 patients per million (95% CI, 4.2-11.8), a figure higher than previous estimates in many areas, but similar to those found in other southern Europe countries. The north-south difference may represent real geographic differences in prevalence, but it might be due to the fact that most of the data come from registries with a lower than expected catchment. Many patients are not being followed up in centers of reference, do not have genetic diagnosis, and are not members of patients' associations, suggesting that there is room for considerable improvement in their care.
    Actas Dermo-Sifiliográficas 06/2013;
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    A Batalla, I García-Doval, G Peón, C de la Torre
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    ABSTRACT: The study of quality of life in patients with skin disorders has become more important in recent decades. In the case of lupus erythematosus, most quality-of-life studies have focused on the systemic form of the disease, with less attention being paid to the cutaneous form. The main objective of this study was to evaluate quality of life in patients with cutaneous lupus erythematosus (CLE) using a dermatology-specific questionnaire: the Dermatology Life Quality Index (DLQI). Our secondary objective was to investigate associations between DLQI scores and other aspects of the disease. Thirty-six patients with CLE completed the DLQI questionnaire. Other factors assessed were disease severity (measured using the Cutaneous Lupus Erythematosus Disease Area and Severity Index), time since diagnosis, body surface area affected, previous and current treatments, and the presence of criteria for systemic lupus erythematosus (SLE). According to the DLQI, CLE had a moderate, very large, or extremely large effect on quality of life in 50% of the patients analyzed (18/36). No significant associations were found between DLQI scores and disease severity, time since diagnosis, body surface area affected, number, type, or duration of pharmacologic treatments, or the presence or absence of SLE criteria. CLE has a significant and lasting effect on patient quality of life. This effect is probably primarily due to multiple factors, including the chronic nature of the disease, the visibility of the lesions, and the fact that they can cause disfigurement.
    Actas Dermo-Sifiliográficas 06/2013;
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    ABSTRACT: BACKGROUND: Dystrophic Epidermolysis Bullosa (DEB) is a rare genodermatosis (7 cases per million) that causes blisters and erosions with minor trauma in skin and mucosa, and other systemic complications. A recently updated systematic review showed that the research evidence about DEB therapies is poor. As new trials in DEB are difficult and expensive, it is important to prioritizise research that patients and clinicians consider more relevant.Objectives: To describe and prioritize the most important uncertainties about DEB treatment shared by patients, carers and health care professionals (HCPs) in order to promote research in those areas. METHODS: A DEB Priority Setting Partnership (PSP) was established, including patients, carers and HCPs. DBE uncertainties were gathered from patients and clinicians, and prioritized in a transparent process, using the methodology advocated by the James Lind Alliance. RESULTS: In the consultation stage, 323 uncertainties were submitted by 58 participants. Once the duplicated and non-treatment uncertainties were removed, the remainder were reduced to a list of 24 most voted questions. These 24 uncertainties were prioritized in a final workshop where a balanced number of patients, carers and HCPs selected the top 10 therapy uncertainties. The final list includes interventions in wound care, itch and pain management, treatment and prevention of syndactyly, cancer prevention and future promising therapies. CONCLUSIONS: The final list of the top 10 treatment uncertainties on the management of DEB provides guidance for researchers and funding bodies, to ensure that future research answers questions that are important to both clinicians and patients. The method proposed by the James Lind Alliance is feasible for very rare disorders.
    Orphanet Journal of Rare Diseases 04/2013; 8(1):61. · 4.32 Impact Factor
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    P Davila-Seijo, A Batalla, I Garcia-Doval
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    ABSTRACT: BACKGROUND AND OBJECTIVE: Systematic reviews are one of the most important sources of information for evidence-based medicine. However, there is a general impression that these reviews rarely report results that provide sufficient evidence to change clinical practice. The aim of this study was to determine the percentage of Cochrane Skin Group reviews reporting results with the potential to guide clinical decision-making. MATERIAL AND METHODS: We performed a bibliometric analysis of all the systematic reviews published by the Cochrane Skin Group up to 16 August, 2012. We retrieved 55 reviews, which were analyzed and graded independently by 2 investigators into 3 categories: 0 (insufficient evidence to support or reject the use of an intervention), 1 (insufficient evidence to support or reject the use of an intervention but sufficient evidence to support recommendations or suggestions), and 2 (sufficient evidence to support or reject the use of an intervention). RESULTS: Our analysis showed that 25.5% (14/55) of the studies did not provide sufficient evidence to support or reject the use of the interventions studied, 45.5% (25/25) provided sufficient but not strong evidence to support recommendations or suggestions, and 29.1% (16/55) provided strong evidence to support or reject the use of 1 or more of the interventions studied. CONCLUSIONS: Most of the systematic reviews published by the Cochrane Skin Group provide useful information to improve clinical practice. Clinicians should read these reviews and reconsider their current practice.
    Actas Dermo-Sifiliográficas 04/2013;
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    ABSTRACT: BACKGROUND: Several national prospective registries of psoriatic patients treated with systemic therapies are running, with the aim of describing the population treated, safety and effectiveness of these treatments, especially biologics. Psonet is an initiative to pool data from these registries. OBJECTIVES: To describe psoriasis therapy in Psonet countries, using baseline data of patients included in these registries. METHODS: We collected data from Psocare (Italy), Dermbio (Denmark), Biobadaderm (Spain), Clalit Health Services (Israel), Australasian Psoriasis Registry, Psobest (Germany), and AMC Medical Center Registry (Netherlands). We described previous use of drugs at the time that patients started a new classic systemic drug or any biologic drug. RESULTS: Data from 20,232 patients was pooled in our analysis (9,668 treated with biologics, 10,564 with other systemic therapies). At a given time in the life course of psoriasis, we have shown large between country heterogeneity on the previous use of systemic drugs for psoriasis and relevant rates of use of biologic drugs in potentially off-label use (first line use and use in psoriasis forms different from plaque psoriasis). Variability in therapy is larger than variability in available patient characteristics likely to influence therapy. CONCLUSIONS: We have shown the presence of large heterogeneity on the use of systemic drugs for psoriasis in participating countries, including differences in patient access to biologics amongst the participating countries. This might be an indicator of unwarranted clinical variation in some countries: a marker of inefficient or less safe use of systemic drugs for psoriasis, and requires further study.
    British Journal of Dermatology 03/2013; · 3.76 Impact Factor
  • A. Batalla, I. García-Doval, G. Peón, C. de la Torre
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    ABSTRACT: Background and objectives The study of quality of life in patients with skin disorders has become more important in recent decades. In the case of lupus erythematosus, most quality-of-life studies have focused on the systemic form of the disease, with less attention being paid to the cutaneous form. The main objective of this study was to evaluate quality of life in patients with cutaneous lupus erythematosus (CLE) using a dermatology-specific questionnaire: the Dermatology Life Quality Index (DLQI). Our secondary objective was to investigate associations between DLQI scores and other aspects of the disease. Material and methods Thirty-six patients with CLE completed the DLQI questionnaire. Other factors assessed were disease severity (measured using the Cutaneous Lupus Erythematosus Disease Area and Severity Index), time since diagnosis, body surface area affected, previous and current treatments, and the presence of criteria for systemic lupus erythematosus (SLE). Results According to the DLQI, CLE had a moderate, very large, or extremely large effect on quality of life in 50% of the patients analyzed (18/36). No significant associations were found between DLQI scores and disease severity, time since diagnosis, body surface area affected, number, type, or duration of pharmacologic treatments, or the presence or absence of SLE criteria. Conclusion CLE has a significant and lasting effect on patient quality of life. This effect is probably primarily due to multiple factors, including the chronic nature of the disease, the visibility of the lesions, and the fact that they can cause disfigurement.
    Actas Dermo-Sifiliográficas 01/2013; 104(9):800–806.
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    ABSTRACT: Introduction  The incidence of tuberculosis (TB) or the prevalence of latent tuberculosis infection (LTBI) in psoriasis patients has not been described in the Spanish population. We carried out a study with the objectives: (i) To describe the incidence of TB in patients with psoriasis on systemic treatment in the Spanish population; (ii) To determine the prevalence of LTBI in patients who are candidates for biological treatment; and (iii) To investigate the level of compliance with current recommendations for LTBI and TB screening. Methods  Data were obtained from BIOBADADERM (Spanish registry for systemic biological and non-biological treatments in psoriasis). An analysis was performed of the exposed cohort to determine the prevalence of LTBI and to describe compliance with the screening guidelines. Results  A total of 1425 patients were registered in BIOBADADERM. They included 793 (56%) patients exposed to biological treatment and 632 (44%) treated with conventional systemic drug. Overall follow-up was 3720 person-years. Of the 793, 20.5% (163) were diagnosed with LTBI before starting biological treatment. The rate of active TB for the exposed cohort was 145 cases × 100 000 patient-years (95% CI 54-389). No case of TB was found in the control group. Screening for LTBI was performed in 83% of the exposed sample. Conclusion  Patients with psoriasis who are exposed to biological treatment appear to be at greater risk for tuberculosis. In Spain, up to 20% of patients with psoriasis who are candidates for biological therapy have LTBI. There continues to be a significant percentage of errors in compliance with clinical guidelines.
    Journal of the European Academy of Dermatology and Venereology 11/2012; · 2.69 Impact Factor
  • A. Batalla, I. García-Doval
    Actas Dermo-Sifiliográficas 11/2012; 103(9):846–847.
  • Journal of the American Academy of Dermatology 10/2012; 67(4):e134-6. · 4.91 Impact Factor

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