Intervenciones para el carcinoma basocelular cutáneo (revisión Cochrane): Resumen de las principales comparaciones e interpretación práctica de los resultados / Interventions for Basal Cell Carcinoma: Summary of Main Comparisons From a Cochrane Review and a Practical Interpretation of Findings

Existen numerosas modalidades de tratamiento para el manejo de los carcinomas basocelulares (CBC), pero se desconoce la real eficacia y seguridad entre las alternativas quirúrgicas y no quirúrgicas disponibles. Este artículo resume la evidencia encontrada en la reciente revisión Cochrane de Thomson et al. y facilita la interpretación de sus resultados entre la comunidad científica iberolatinoamericana. La gran mayoría de la evidencia evaluada proviene de estudios individuales que impidieron la realización de una revisión sistemática cuantitativa. La escisión quirúrgica convencional continúa siendo la terapia más eficaz para el tratamiento de los CBC de bajo riesgo. La mayoría de estudios incluyeron tamaños de muestra pequeños y algunos tuvieron problemas con el cegamiento, lo que influiría en resultados subjetivos tales como el dolor o la cosmesis. Existe una falta de estandarización en relación con los desenlaces de recurrencia y de resultados cosméticos, lo que en conjunto afecta no solo la validez interna sino también la validez externa y la reproducibilidad de los estudios (AU)

Numerous surgical and nonsurgical modalities are available to treat basal cell carcinoma (BCC), but their true effectiveness and safety is unknown. This article summarizes the evidence presented in a recent Cochrane review and aims to facilitate the interpretation of the review's findings for the Spanish and Latin American scientific communities. Much of the evidence the reviewers found came from single studies, preventing meta-analysis. Conventional surgical excision continues to be the most effective treatment for low-risk BCC. Most studies had small sample sizes, and some had problems with blinding, limitations which will have affected the assessment of subjective outcomes, such as pain and cosmetic results. The authors identified a lack of standardization in relation to recurrences and cosmetic outcomes that threatens not only the internal validity of the studies but also their external validity and reproducibility (AU)

[Translated article] Interventions for Basal Cell Carcinoma: Summary of Main Comparisons From a Cochrane Review and a Practical Interpretation of Findings / Intervenciones para el carcinoma basocelular cutáneo (revisión Cochrane): Resumen de las principales comparaciones e interpretación práctica de los resultados

Numerous surgical and nonsurgical modalities are available to treat basal cell carcinoma (BCC), but their true effectiveness and safety is unknown. This article summarizes the evidence presented in a recent Cochrane review and aims to facilitate the interpretation of the review's findings for the Spanish and Latin American scientific communities. Much of the evidence the reviewers found came from single studies, preventing meta-analysis. Conventional surgical excision continues to be the most effective treatment for low-risk BCC. Most studies had small sample sizes, and some had problems with blinding, limitations which will have affected the assessment of subjective outcomes, such as pain and cosmetic results. The authors identified a lack of standardization in relation to recurrences and cosmetic outcomes that threatens not only the internal validity of the studies but also their external validity and reproducibility (AU)

Existen numerosas modalidades de tratamiento para el manejo de los carcinomas basocelulares (CBC), pero se desconoce la real eficacia y seguridad entre las alternativas quirúrgicas y no quirúrgicas disponibles. Este artículo resume la evidencia encontrada en la reciente revisión Cochrane de Thomson et al. y facilita la interpretación de sus resultados entre la comunidad científica iberolatinoamericana. La gran mayoría de la evidencia evaluada proviene de estudios individuales que impidieron la realización de una revisión sistemática cuantitativa. La escisión quirúrgica convencional continúa siendo la terapia más eficaz para el tratamiento de los CBC de bajo riesgo. La mayoría de estudios incluyeron tamaños de muestra pequeños y algunos tuvieron problemas con el cegamiento, lo que influiría en resultados subjetivos tales como el dolor o la cosmesis. Existe una falta de estandarización en relación con los desenlaces de recurrencia y de resultados cosméticos, lo que en conjunto afecta no solo la validez interna sino también la validez externa y la reproducibilidad de los estudios (AU)

Interventions for Basal Cell Carcinoma: Summary of Main Comparisons From a Cochrane Review and a Practical Interpretation of Findings. / Intervenciones para el carcinoma basocelular cutáneo (revisión Cochrane): Resumen de las principales comparaciones e interpretación práctica de los resultados.

Numerous surgical and nonsurgical modalities are available to treat basal cell carcinoma (BCC), but their true effectiveness and safety is unknown. This article summarizes the evidence presented in a recent Cochrane review and aims to facilitate the interpretation of the review's findings for the Spanish and Latin American scientific communities. Much of the evidence the reviewers found came from single studies, preventing meta-analysis. Conventional surgical excision continues to be the most effective treatment for low-risk BCC. Most studies had small sample sizes, and some had problems with blinding, limitations which will have affected the assessment of subjective outcomes, such as pain and cosmetic results. The authors identified a lack of standardization in relation to recurrences and cosmetic outcomes that threatens not only the internal validity of the studies but also their external validity and reproducibility.

Construct validity and responsiveness of the Colombian version of Skindex-29.

BACKGROUND: In recent years, the need for international, objective, patient-reported outcomes measures has grown as international collaboration has increased. As most quality-of-life scales have been developed in English, there is a growing need to adapt them transculturally to obtain equivalence between the original instrument and the adapted scale. OBJECTIVES: To assess the construct and convergent-discriminant validity and responsiveness of the Colombian version of Skindex-29. METHODS: The cross-sectional and longitudinal validity and responsiveness were tested in both healthy and dermatology patients. Construct validity was tested through a confirmatory factor analysis. The convergent-discriminant validity was assessed by examining the Spearman correlation coefficient. Change sensitivity was tested by means of the standardized response mean. The effect size and the minimum detectable change were also assessed. RESULTS: A total of 265 participants were included; 21·1% were healthy individuals, and 78·9% patients had either inflammatory or noninflammatory skin diseases. Confirmatory factor analysis showed an adequate comparative fit index and Tucker-Lewis index adjustment for the root mean square error of approximation. Convergent validity showed moderate correlations between the emotions, functioning and physical function or physical role domains. Discriminant validity showed low correlations between overall domains for both scales. Sensitivity to change at the first and third month showed effect sizes in global Skindex scores of 0·92 and 0·82, respectively. CONCLUSIONS: The Colombian version of Skindex-29 is a valid and clinically sensitive instrument, which can be used for clinical practice and for research to measure the impact of skin diseases on the quality of life of dermatology patients.

Severe Hepatitis C Recurrence as a Risk Factor for Opportunistic Infections in Liver Transplant Recipients.

OBJECTIVE: The aim of the study was to determine the clinical characteristics, frequency of opportunistic infections (OI), and the outcomes for liver transplant recipients with severe hepatitis C virus (HCV) recurrence. In addition, the objective was to evaluate HCV recurrence as a risk factor for developing an OI. METHODS: We conducted a retrospective observational study recording all liver transplant recipients from July 1, 2003, to December 31, 2012. Patients with liver disease due to HCV were selected. Active surveillance of infections was conducted periodically, and patients were classified according to presence of severe HCV recurrence. RESULTS: Three hundred seventy patients underwent liver transplantation because of chronic HCV. One hundred forty-seven patients presented severe recurrence (SR) (49%) and 50 (17%) of them had post-liver transplant cholestatic hepatitis C. Patients with SR presented OI, especially cytomegalovirus (CMV) infections and invasive fungal infections, more frequently than patients without SR (33% vs 13%; P < .001). From the diagnosis of SR to the presentation of OI, the median number of days was 169 (6-2083). Acute allograft rejection (OR 1.8 95% confidence interval [CI] 1.1-3.3) donor age ≥60 years (OR 2.9 95% CI 1.3-6.8), and SR (OR 2.8, 95% CI 1.6-5.1) were independently associated with the development of OI in liver transplant recipients. CONCLUSION: A high index of suspicion of opportunistic infections must be maintained when faced with severe HCV recurrence in liver transplant recipients. Moreover, active surveillance against CMV infection and other prophylactic strategies against opportunistic infections should be considered.

Photodynamic Therapy Interventions in Facial Photodamage: A Systematic Review / Terapia fotodinámica en el fotodaño facial: revisión sistemática

INTRODUCTION: Photodynamic therapy (PDT) involves the combination of a light source and a photosensitizing agent to induce tissue damage via the generation of singlet oxygen. Although topical PDT has been approved for other indications, its use in facial photodamage is uncertain. AIMS: To assess the efficacy and safety of PDT in facial skin photoaging. METHODS: All randomized clinical trials (RCTs) evaluating the efficacy and safety of any form of topical PDT for the treatment of facial photodamage (dermatoheliosis) or photoaging in patients older than 18 years, were included. Photodynamic-therapy using any topical photosensitizing agent at any dose, and with any light-source, were considered. Comparators were chemical exfoliation, intense pulsed light (IPL), light emitting diodes (LED), dermabrasion or microdermabrasion, ablative or non-ablative lasers, injectables, surgery, placebo and/or no treatment. A systematic search in PubMed, Embase, Lilacs, Google Scholar and RCT's registry databases, was performed. RESULTS: Search was conducted up to May 4th 2016. Four authors independently selected and assessed methodological quality of each RCT. According to inclusion criteria, twelve studies were included (6 aminolevulinate (ALA) trials and 6 methyl aminolevulinate (MAL) trials), but the majority of them had methodological constraints particularly in randomization description and patients/outcome assessors blindness. DISCUSSION AND CONCLUSIONS: Overall results indicated that PDT either with ALA or with MAL was effective and safe for facial photodamage treatment, but high quality of evidence was found mainly for MAL studies

INTRODUCCIÓN: La terapia fotodinámica (TF) incluye una combinación de una fuente de luz y un agente fotosensibilizante para inducir daño tisular a través de la generación de oxígeno singlete. Aunque la TF se ha aprobado para otras indicaciones, su uso en el fotodaño facial resulta incierto. OBJETIVO: Valorar la eficacia y seguridad de la TF en el fotoenvejecimiento de la piel del rostro. MÉTODOS: Se incluyeron todos los ensayos clínicos aleatorizados (ECA) que evalúan la eficacia y seguridad de cualquier forma de TF tópica para el tratamiento del fotodaño facial (dermatoheliosis) o fotoenvejecimiento en pacientes mayores de 18 años. Se consideró la TF que utiliza cualquier dosis de agente fotosensibilizante, así como cualquier fuente lumínica. Los comparadores fueron: exfoliación química, luz pulsada intensa (IPL), diodo emisor de luz (LED), dermoabrasión o microdermoabrasión, láseres ablativos o no ablativos, inyectables, cirugía, placebo y/o ausencia de tratamiento. Se llevó a cabo una búsqueda sistemática en las bases de datos de los registros de PubMed, Embase, Lilacs, Google Scholar y ECA. RESULTADOS: La búsqueda se realizó hasta el mes de mayo de 2016. Cuatro autores seleccionaron y valoraron de manera independiente la calidad metodológica de cada ECA. Con arreglo a los criterios de inclusión, se incluyeron 12 estudios (6 ensayos sobre aminolevulinato [ALA] y 6 sobre metiloaminolevulinato [MAL]), aunque la mayoría de ellos contenían limitaciones metodológicas, particularmente en cuanto a la descripción de la aleatorización y la valoración a ciegas de los asesores de los pacientes/resultados. DISCUSIÓN Y CONCLUSIONES: Los resultados generales indicaron que la TF, tanto con ALA como con MAL, era una terapia efectiva y segura para el tratamiento del fotodaño facial, aunque se encontró evidencia de alta calidad principalmente en los estudios realizados sobre MAL

Photodynamic Therapy Interventions in Facial Photodamage: A Systematic Review.

INTRODUCTION: Photodynamic therapy (PDT) involves the combination of a light source and a photosensitizing agent to induce tissue damage via the generation of singlet oxygen. Although topical PDT has been approved for other indications, its use in facial photodamage is uncertain. AIMS: To assess the efficacy and safety of PDT in facial skin photoaging. METHODS: All randomized clinical trials (RCTs) evaluating the efficacy and safety of any form of topical PDT for the treatment of facial photodamage (dermatoheliosis) or photoaging in patients older than 18 years, were included. Photodynamic-therapy using any topical photosensitizing agent at any dose, and with any light-source, were considered. Comparators were chemical exfoliation, intense pulsed light (IPL), light emitting diodes (LED), dermabrasion or microdermabrasion, ablative or non-ablative lasers, injectables, surgery, placebo and/or no treatment. A systematic search in PubMed, Embase, Lilacs, Google Scholar and RCT's registry databases, was performed. RESULTS: Search was conducted up to May 4th 2016. Four authors independently selected and assessed methodological quality of each RCT. According to inclusion criteria, twelve studies were included (6 aminolevulinate (ALA) trials and 6 methyl aminolevulinate (MAL) trials), but the majority of them had methodological constraints particularly in randomization description and patients/outcome assessors blindness. DISCUSSION AND CONCLUSIONS: Overall results indicated that PDT either with ALA or with MAL was effective and safe for facial photodamage treatment, but high quality of evidence was found mainly for MAL studies.

Mannose-Binding Lectin-Deficient Donors Increase the Risk of Bacterial Infection and Bacterial Infection-Related Mortality After Liver Transplantation.

Mannose-binding lectin (MBL) is synthesized by the liver and binds to microbes. MBL2 gene polymorphisms produce intermediate/low/null or normal MBL serum levels (MBL-deficient or MBL-sufficient phenotypes, respectively). We aimed to evaluate the incidence and severity of infection, rejection, and survival within 1 year after liver transplantation (LT) according to donor and recipient MBL2 gene polymorphisms. A repeated-event analysis for infection episodes (negative binomial regression, Andersen-Gill model) was performed in 240 LTs. Four hundred twenty-eight infectious episodes (310 bacterial, 15 fungal, 65 cytomegalovirus [CMV]-related, and 38 viral non-CMV-related episodes) and 48 rejection episodes were recorded. The main bacterial infections were urinary (n = 82, 26%) and pneumonia (n = 69, 22%). LT recipients of MBL-deficient livers had a higher risk of bacterial infection (incidence rate ratio [IRR] 1.48 [95% confidence interval 1.04-2.09], p = 0.028), pneumonia (IRR 2.4 [95% confidence interval 1.33-4.33], p = 0.013), and septic shock (IRR 5.62 [95% confidence interval 1.92-16.4], p = 0.002) compared with recipients of MBL-deficient livers. The 1-year bacterial infection-related mortality was higher in recipients of MBL-deficient versus MBL-sufficient livers (65.8% vs. 56.1%, respectively; p = 0.0097). The incidence of rejection, viral, or fungal infection was similar in both groups. Recipient MBL2 genotype did not significantly increase the risk of bacterial infection. LT recipients of MBL-deficient livers have a higher risk of bacterial infection, pneumonia, septic shock, and 1-year bacterial infection-related mortality after LT.

The impact of skin diseases on quality of life: a multicenter study / El impacto de las enfermedades cutáneas en la calidad de vida: un estudio multicéntrico

INTRODUCTION: To date, no formal study has been published regarding how Colombian patients with skin disorders could be affected according to their perception of disease. OBJECTIVE: To determine the impact in quality of life of skin diseases in a Colombian population. METHODS: This multicenter study included patients with skin disease from almost the whole country. Individuals >18 years old; of any gender; with any skin disease and who signed informed consent, were included. We applied the Colombian validated version of the Skindex-29 instrument. RESULTS: A total of 1896 questionnaires had sufficient information for the analyses. No significant differences in sociodemographic characteristics of patients who returned the questionnaire incomplete vs. complete, were found. Participants mean age was 41.5 years. There were no statistical differences in men vs. women regarding the global (p = 0.37), symptoms (p = 0.71) and emotions (p = 0.32) domains, whereas statistical differences were found in the function domain (p = 0.04; Mann-Whitney U test). Psoriasis, contact dermatitis, atopic dermatitis, urticaria, hair disorders, Hansen's disease, scars, hyperhidrosis and genital human papillomavirus disease scored the highest. Limitations. Skindex-29 score variability as a result of differences in the location of the skin lesions, their inflammatory or non-inflammatory nature, and the start of therapy. CONCLUSIONS: Even the most localized or asymptomatic skin lesion in our population leads to a disruption at some level of patient's wellness. This study adds well supported scientific data of the burden of skin diseases worldwide

INTRODUCCIÓN: En Colombia se carece de estudios que hayan evaluado formalmente el impacto de las enfermedades dermatológicas en la calidad de vida de los pacientes que las padecen. OBJETIVO: Determinar el impacto en la calidad de vida de las enfermedades cutáneas en una población colombiana. MÉTODOS: Estudio multicéntrico que incluyó a individuos>18 años de edad; de cualquier sexo, con cualquier trastorno cutáneo y que firmaron el consentimiento informado. Se aplicó la versión validada en Colombia del instrumento Skindex-29. RESULTADOS: Un total de 1.896 cuestionarios se incluyeron en el análisis. No se observaron diferencias significativas en las características sociodemográficas entre los que devolvieron el cuestionario incompleto vs. completo. La edad promedio fue de 41,5 años. No hubo diferencias significativas entre hombres y mujeres con respecto al puntaje global del instrumento, ni de los dominios sintomático o emocional, mientras que sí las hubo en el dominio funcional. Entre las enfermedades que más afectaron la calidad de vida se incluyen: psoriasis, dermatitis de contacto, dermatitis atópica, urticaria, trastornos capilares, lepra, cicatrices, hiperhidrosis y las verrugas genitales. Limitaciones. Las puntuaciones del Skindex-29 mostraron una gran variabilidad explicable por diferencias en la localización de las lesiones de la piel, su naturaleza inflamatoria/no inflamatoria, y la iniciación o no del tratamiento. CONCLUSIONES: Cualquier lesión dermatológica por más localizada o asintomática que sea, condujo a una alteración en algún grado de la calidad de vida dermatológica. Este estudio añade soporte científico a la carga de enfermedad que generan los trastornos cutáneos en el mundo

The impact of skin diseases on quality of life: A multicenter study.

INTRODUCTION: To date, no formal study has been published regarding how Colombian patients with skin disorders could be affected according to their perception of disease. OBJECTIVE: To determine the impact in quality of life of skin diseases in a Colombian population. METHODS: This multicenter study included patients with skin disease from almost the whole country. Individuals >18 years old; of any gender; with any skin disease and who signed informed consent, were included. We applied the Colombian validated version of the Skindex-29 instrument. RESULTS: A total of 1896 questionnaires had sufficient information for the analyses. No significant differences in sociodemographic characteristics of patients who returned the questionnaire incomplete vs. complete, were found. Participants mean age was 41.5 years. There were no statistical differences in men vs. women regarding the global (p=0.37), symptoms (p=0.71) and emotions (p=0.32) domains, whereas statistical differences were found in the function domain (p=0.04; Mann-Whitney U test). Psoriasis, contact dermatitis, atopic dermatitis, urticaria, hair disorders, Hansen's disease, scars, hyperhidrosis and genital human papillomavirus disease scored the highest. LIMITATIONS: Skindex-29 score variability as a result of differences in the location of the skin lesions, their inflammatory or non-inflammatory nature, and the start of therapy. CONCLUSIONS: Even the most localized or asymptomatic skin lesion in our population leads to a disruption at some level of patient's wellness. This study adds well supported scientific data of the burden of skin diseases worldwide.

A double-blind randomized controlled trial to assess the efficacy of daylight photodynamic therapy with methyl-aminolevulinate vs. Placebo and daylight in patients with facial photodamage / Ensayo clínico aleatorio controlado, doble ciego para valorar la eficacia de la terapia fotodinámica con luz de día con metilaminolevulinato frente a placebo y luz de día en pacientes con fotodaño facial

BACKGROUND: Daylight PDT (dPDT) is easy to use and does not require light equipment. Such therapy has been exhaustively proved to be successful in the treatment of actinic keratosis, but its use in skin photodamage remains unclear. OBJECTIVE: To evaluate dPDT's efficacy in skin facial photodamage. PATIENTS AND METHODS: This was a parallel-group double-blind, randomized placebo-controlled trial. Sixty participants with symmetric facial photodamage were allocated to topical methyl aminolevulinate (MAL) and daylight vs. matching placebo and daylight. Primary outcome was global photodamage improvement/failure 1 month after the third session. Secondary outcomes included: pain evaluation; specific photodamage severity scores; sun irradiance quantification and Skindex-29 scores. Adverse events were also investigated. RESULTS: Primary analysis included all randomized patients. All patients sun-exposed for 120min in 3 sessions. The risk of failure was lower in the MAL-dPDT group than in the placebo plus daylight group (RR: 0.18; 95% CI: 0.08-0.41). Mean solar irradiance (W/m2) during the first, second and third sessions was 480.82, 430.07 and 435.84, respectively. Items 5 and 14 of Skindex-29 in the MAL-dPDT group showed statistical significant differences. Two patients in the MAL-dPDT group had serious and non-serious events not directly related to the product. CONCLUSION: dPDT with MAL was un-painful, effective and safe for the treatment of facial photodamage. Herpes simplex prophylaxis should be considered before sessions)

INTRODUCCIÓN: La terapia fotodinámica con luz-día (TFDd) es fácil de usar y no requiere de equipo alguno. Tal terapia ha demostrado ser útil en el tratamiento de las queratosis actínicas, pero su uso en el fotodaño no es claro. OBJETIVO: Evaluar la eficacia de la TFDd en el fotodaño facial. Pacientes y MÉTODOS: Se realizó un ensayo clínico doble-ciego controlado con placebo y con asignación aleatoria. Sesenta participantes con fotodaño facial simétrico se asignaron a recibir bien TFD con Metil-Aminolevulinato (MAL) y luz de día o placebo y luz de día. El resultado primario fue la mejoría/fracaso en el fotodaño facial global un mes después de la tercera sesión. Los resultados secundarios incluyeron: dolor; fotodaño específico, irradiancia recibida y la puntuación en el Skindex-29. RESULTADOS: Todos los pacientes se expusieron a la luz de día durante 120 minutos en 3 sesiones. El riesgo de fracaso fue menor en el grupo de TFD con MAL y luz de día que en el grupo placebo (RR:0,18; 95%; IC:0,08 a 0.41). La media de la irradiancia solar (W.m-2) durante la primera, segunda y tercera sesión fue de 480,82, 430,07 y 435,84, respectivamente. Los ítems 5 y 14 del Skindex-29 en el grupo de TFDd con MAL mostraron diferencias estadísticamente significativas. Dos pacientes en el mismo grupo presentaron eventos adversos serios y no serios pero estos no tuvieron relación directa con el producto evaluado. CONCLUSIÓN: La TFDd con MAL fue es un tratamiento indoloro, eficaz y seguro para el tratamiento del fotoenvejecimiento facial. La profilaxis del Herpes simple debe ser considerada antes de cada sesión

Análisis de la calidad de los ensayos clínicos publicados en revistas dermatológicas publicadas en español entre 1997 y 2012 / Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012

INTRODUCCIÓN: La relevancia del ensayo controlado con asignación aleatoria (ECA) para determinar si existe una asociación entre una intervención y un desenlace está determinada por su calidad y rigor científico. OBJETIVO: Evaluar la calidad metodológica de los ECA publicados en revistas dermatológicas en español. MÉTODOS: Se realizó una búsqueda manual y sistemática de los ECA publicados en las revistas de Dermatología españolas y latinoamericanas entre 1997 (publicación de los criterios CONSORT) y 2012. Se determinó el riesgo de sesgo de cada ECA, evaluando los siguientes dominios: generación de la secuencia aleatoria, ocultamiento de la asignación, cegamiento de los pacientes/evaluadores de desenlaces, datos faltantes y seguimiento de pacientes. Se identificaron la fuente de financiación de los estudios y el reporte de conflictos de interés. RESULTADOS: Se identificaron 70 ECA publicadas en 21 revistas. La mayoría de los ECA tuvo un alto riesgo de sesgo, principalmente por falta de reporte de los aspectos metodológicos importantes. Solo 15 estudios declararon fuentes de financiación. DISCUSIÓN Y CONCLUSIONES: A pesar del número considerable de revistas existentes en España y Latinoamérica, en los 15 años estudiados se han publicado pocos ECA. La mayoría de los estudios presentó problemas de calidad importantes, al carecer de información metodológica que permitiera evaluar su calidad y a las falencias en el reporte de las fuentes de financiación y de los conflictos de interés de los autores. La investigación clínica experimental dermatológica que se publica en Ibero-Latinoamérica debe mejorar ostensiblemente tanto en su diseño como en su reporte de resultados

INTRODUCTION: The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. OBJECTIVE: To assess the methodological quality of RCTs published in Spanish-language dermatology journals. METHODS: By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. RESULTS: The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. DISCUSSION AND CONCLUSIONS: In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results

Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group.

Conventional PDT (c-PDT) is a widely used and approved non-invasive treatment for actinic keratosis (AK). Recent clinical, histological and immunohistochemical observations have shown that c-PDT with methyl aminolevulinate (MAL) may also partially reverse the signs of photodamage. However, pain and the need for special light source equipment are limiting factors for its use, especially in the treatment of large areas. More recently, daylight PDT (DL-PDT) has been shown to be similar to c-PDT in the treatment of AK, nearly painless and more convenient to perform. To establish consensus on recommendations for the use of MAL DL-PDT in patients with large-scale photodamaged skin. The expert group was comprised of eight dermatologists. Consensus was developed based on the personal experience of the experts in c-PDT and DL-PDT, and results of an extensive literature review. MAL DL-PDT for large areas of photodamaged skin was evaluated and recommendations based on broad clinical experience were provided. As supported by evidence-based data from multicentre studies conducted in Australia and Europe, the authors defined the concept of 'actinic field damage' which refers to photodamage associated with actinic epidermal dysplasia, and provide comprehensive guidelines for the optimal use of DL-PDT in the treatment of actinic field damage. The authors concluded that MAL DL-PDT has a similar efficacy to c-PDT at 3-month (lesion complete response rate of 89% vs. 93% in the Australian study and 70% vs. 74% in the European study (95% C.I. = [-6.8;-0.3] and [-9.5;2.4] respectively) and 6-month follow-ups (97% maintenance of complete lesion response) in the treatment of AKs. The authors agree that DL-PDT is not only efficacious but also nearly pain-free and easy to perform, and therefore results in high patient acceptance especially for the treatment of areas of actinic field damage.

A double-blind randomized controlled trial to assess the efficacy of daylight photodynamic therapy with methyl-aminolevulinate vs. Placebo and daylight in patients with facial photodamage.

BACKGROUND: Daylight PDT (dPDT) is easy to use and does not require light equipment. Such therapy has been exhaustively proved to be successful in the treatment of actinic keratosis, but its use in skin photodamage remains unclear. OBJECTIVE: To evaluate dPDT's efficacy in skin facial photodamage. PATIENTS AND METHODS: This was a parallel-group double-blind, randomized placebo-controlled trial. Sixty participants with symmetric facial photodamage were allocated to topical methyl aminolevulinate (MAL) and daylight vs. matching placebo and daylight. Primary outcome was global photodamage improvement/failure 1 month after the third session. Secondary outcomes included: pain evaluation; specific photodamage severity scores; sun irradiance quantification and Skindex-29 scores. Adverse events were also investigated. RESULTS: Primary analysis included all randomized patients. All patients sun-exposed for 120min in 3 sessions. The risk of failure was lower in the MAL-dPDT group than in the placebo plus daylight group (RR: 0.18; 95% CI: 0.08-0.41). Mean solar irradiance (W/m(2)) during the first, second and third sessions was 480.82, 430.07 and 435.84, respectively. Items 5 and 14 of Skindex-29 in the MAL-dPDT group showed statistical significant differences. Two patients in the MAL-dPDT group had serious and non-serious events not directly related to the product. CONCLUSION: dPDT with MAL was un-painful, effective and safe for the treatment of facial photodamage. Herpes simplex prophylaxis should be considered before sessions.

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

INTRODUCTION: The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. OBJECTIVE: To assess the methodological quality of RCTs published in Spanish-language dermatology journals. METHODS: By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. RESULTS: The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. DISCUSSION AND CONCLUSIONS: In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results.