fluocinonide
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Eccemas agudos exógenos o endógenos, eccema seborreico y tratamiento coadyuvante de la psoriasis.
Contraindicaciones
Absolutas
- Hipersensibilidad a fluocinónida o a alguno de los componentes.
- Tuberculosis o sífilis cutánea, infecciones víricas, bacterianas o fúngicas, rosácea, dermatitis perioral, úlcera, acné, atrofia cutánea, ojos o heridas profundas.
Advertencias clínicas
- Advertencia mayor · Usar la menor cantidad eficaz durante el menor tiempo posible. Las superficies extensas, el uso prolongado, la barrera cutánea alterada y la oclusión aumentan la absorción y pueden causar supresión reversible del eje hipotálamo-hipófisis-suprarrenal, síndrome de Cushing, hiperglucemia o glucosuria; los niños son más susceptibles. — CIMA/AEMPS, ficha técnica 54036
- Evitar el contacto con los ojos. Suspender ante irritación o sensibilización. Si existe una infección cutánea, tratarla; si no responde pronto, suspender el corticoide hasta controlarla. — CIMA/AEMPS, ficha técnica 54036
- No aplicar en zonas intertriginosas, superficies extensas ni bajo oclusión. Usar con precaución si existe circulación deteriorada por riesgo de ulceración. — CIMA/AEMPS, ficha técnica 54036
Embarazo y lactancia
Evitar durante el primer trimestre; después, usar solo si el beneficio justifica el riesgo y evitar zonas extensas, uso prolongado u oclusión. Durante la lactancia, no aplicar en la mama.
Bibliografía reciente (PubMed)
To compare the reported efficacy and costs of available interventions used for the management of oral lichen planus (OLP). A systematic literature search was performed from database inception until March 2021 in MEDLINE via PubMed and the Cochrane library following PRISMA guidelines. Only randomized controlled trials (RCT) comparing an active intervention with placebo or different active interventions for OLP management were considered. Seventy (70) RCTs were included. The majority of evidence suggested efficacy of topical steroids (dexamethasone, clobetasol, fluocinonide, triamcinolone), topical calcineurin inhibitors (tacrolimus, pimecrolimus, cyclosporine), topical retinoids, intra-lesional triamcinolone, aloe-vera gel, photodynamic therapy, and low-level laser therapies for OLP management. Based on the estimated cost per month and evidence for efficacy and side-effects, topical steroids (fluocinonide > dexamethasone > clobetasol > triamcinolone) appear to be more cost-effective than topical calcineurin inhibitors (tacrolimus > pimecrolimus > cyclosporine) followed by intra-lesional triamcinolone. Of common treatment regimens for OLP, topical steroids appear to be the most economical and efficacious option followed by topical calcineurin inhibitors. Large-scale multi-modality, prospective trials in which head-to-head comparisons interventions are compared are required to definitely assess the cost-effectiveness of OLP treatments.
To examine the impact of fluocinonide 0.05% gel formulation for the topical treatment of oral lichen planus (OLP). Through an RCT design, 47 patients with OLP were randomly allocated for topical OLP treatment with fluocinonide 0.05% (n = 23) or placebo (n = 24). Patients were examined for OLP symptoms, signs, disease severity, and extension score changes over 6-month follow-up. After 6 months, in comparison with placebo, patients treated with fluocinonide experienced a significant reduction of OLP symptoms (p = 0.024), signs (p = 0.014), and OLP extension score (p = 0.028). The two-way ANOVA estimation models revealed that treatment with fluocinonide determined, at 6 months, a positive significant effect on the reduced OLP signs (p = 0.017), OLP symptoms (p = 0.026), and OLP extension score (p = 0.028). The multivariate regression analysis highlighted that anxiety, stress, and depression were significant predictors of every analyzed OLP outcome (p < 0.05 for each parameter) and that patients who had baseline anxiety, depression, and stress gained more benefits from fluocinonide at 6-month follow-up. Topical fluocinonide 0.05% was more efficacious compared to placebo in reducing OLP outcomes at 6-month follow-up. Anxiety, depression, and stress were significant predictors of OLP outcomes and positively impacted the treatment with fluocinonide at 6 months.