Eficacia y seguridad del aceite de rosa mosqueta en las lesiones de los dedos provocadas por las punciones capilares para el control glucémico en niños con diabetes tipo 1; un ensayo clínico aleatorizado, abierto, controlado / Efficacy and safety of a rosehip seed oil extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus caused by finger prick blood glucose monitoring; a randomized, open-label, controlled clinical trial

Introducción: Evaluar la seguridad y eficacia de un extracto de aceite de rosa mosqueta en la prevención y tratamiento de las lesiones cutáneas en las manos de los pacientes con diabetes mellitus tipo 1 (DMT1) secundarias a las punciones digitales para el control glucémico. Pacientes y métodos: Estudio prospectivo, aleatorizado, controlado, abierto, con evaluadores ciegos e intervencionista en pacientes de edades entre 6 y 17 años con DMT1 y control intensivo de la glucemia con ≥ 7 punciones capilares diarias durante 12 días. Se evaluaron 3 variables principales (eritema, engrosamiento cutáneo, pérdida de la integridad cutánea) de la siguiente forma: 0: ausente, 1: leve, 2: moderado, 3: intenso. El estudio fue aprobado por el Comité Ético del hospital. Resultados: Se incluyó a 68 niños, por tanto, 136 manos: 80 recibieron aceite de rosa mosqueta y 56 fueron controles. Las características basales de los 2 grupos fueron similares. El 76,3% y el 78,6% presentaban alguna lesión dermatológica inicial, respectivamente. La mediana de valoración global final fue de 0,10 (0,03; 0,30) y de 0,06 (0,00; 0,23), en el grupo de aceite de rosa mosqueta y grupo control, respectivamente. Se encontró una mejoría estadísticamente significativa de la valoración global solo en el grupo control (p = 0,049). No se encontraron diferencias estadísticamente significativas para la comparación de medianas del resto de las variables principales. No se registraron efectos adversos. Conclusión: Se encontró una alta frecuencia de lesiones dermatológicas secundarias a punciones capilares digitales, la mayoría de las cuales fueron lesiones leves. La aplicación de aceite de rosa mosqueta fue segura y no supuso una mejoría en las lesiones dermatológicas

Introduction: This study was intended to assess the efficacy and safety of a rosehip seed oil (RHO) extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus (T1DM) caused by finger prick blood glucose monitoring. Patients and method: A prospective, randomized, controlled, open-label, rater-blinded trial in patients aged 6-17 years with T1DM and intensive blood glucose control (≥ 7 finger pricks daily) for 12 days. Three main variables (erythema, skin thickening, and loss of skin integrity) were assessed using a scale ranging from 0 (absent) to 3 (severe involvement). The study was approved by the ethics committee of the hospital. Results: Sixty-eight children, and thus 136 hands, were included; 80 hands received rosehip seed oil and 56 hands acted as controls. Baseline characteristics of both groups were similar, with 76.3% and 78.6% of the hands respectively showing skin lesions at study start. Median final global assessment was 0.10 (0.03; 0.30) in the group that received rosehip seed oil and 0.06 (0.00; 0.23) in the control group. A statistically significant improvement in global assessment was found in the control group (P=0.049). No significant differences were found when the medians of the other main variables were compared. No adverse effects were recorded. Conclusion: A high prevalence of skin lesions secondary to finger prick glucose monitoring, most of them mild lesions, was found at study start. Treatment with rosehip seed oil was safe and was not effective for improving skin lesions

Efficacy and safety of a rosehip seed oil extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus caused by finger prick blood glucose monitoring; a randomized, open-label, controlled clinical trial. / Eficacia y seguridad del aceite de rosa mosqueta en las lesiones de los dedos provocadas por las punciones capilares para el control glucémico en niños con diabetes tipo 1; un ensayo clínico aleatorizado, abierto, controlado.

INTRODUCTION: This study was intended to assess the efficacy and safety of a rosehip seed oil (RHO) extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus (T1DM) caused by finger prick blood glucose monitoring. PATIENTS AND METHOD: A prospective, randomized, controlled, open-label, rater-blinded trial in patients aged 6-17 years with T1DM and intensive blood glucose control (≥7 finger pricks daily) for 12 days. Three main variables (erythema, skin thickening, and loss of skin integrity) were assessed using a scale ranging from 0 (absent) to 3 (severe involvement). The study was approved by the ethics committee of the hospital. RESULTS: Sixty-eight children, and thus 136 hands, were included; 80 hands received rosehip seed oil and 56 hands acted as controls. Baseline characteristics of both groups were similar, with 76.3% and 78.6% of the hands respectively showing skin lesions at study start. Median final global assessment was 0.10 (0.03; 0.30) in the group that received rosehip seed oil and 0.06 (0.00; 0.23) in the control group. A statistically significant improvement in global assessment was found in the control group (P=0.049). No significant differences were found when the medians of the other main variables were compared. No adverse effects were recorded. CONCLUSION: A high prevalence of skin lesions secondary to finger prick glucose monitoring, most of them mild lesions, was found at study start. Treatment with rosehip seed oil was safe and was not effective for improving skin lesions.