fluocinolone acetonide
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento sintomático de dermatosis sensibles a corticoides en adultos y niños desde 1 año, especialmente en zonas pilosas o visibles.
Contraindicaciones
Absolutas
- Hipersensibilidad a fluocinolona o a alguno de los componentes.
- Tuberculosis, sífilis, infecciones bacterianas, víricas o fúngicas en la zona, rosácea, dermatitis perioral, úlceras, heridas, acné o atrofia cutánea.
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 50031
- 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 50031
- Advertencia mayor · Evitar la retirada brusca tras uso prolongado por riesgo de rebote. En psoriasis se requiere supervisión estrecha por recaída, tolerancia, psoriasis pustulosa o toxicidad. — CIMA/AEMPS, ficha técnica 50031
Interacciones medicamentosas
- LeveOtras preparaciones en la misma zona
Mecanismo: La aplicación simultánea en la misma zona no está recomendada.
Recomendación: No aplicar simultáneamente otras preparaciones sobre el área tratada.
CIMA/AEMPS, ficha técnica 50031https://cima.aemps.es/cima/dochtml/ft/50031/FT_50031.html
Embarazo y lactancia
Evitar durante el primer trimestre; después, usar solo si el beneficio supera el riesgo y evitar zonas extensas, uso prolongado u oclusión. Durante la lactancia, usar con precaución y no aplicar en las mamas.
Bibliografía reciente (PubMed)
- Efficacy of Botulinum Toxin A for the Management of Melasma: A Split-Face, Randomized Control Study.
Melasma management remains challenging due to its multifactorial nature pathogenesis and recurrent nature. Previous studies showed positive effects of botulinum toxin A (BoNT-A) for treating and preventing ultraviolet-induced hyperpigmentation. To evaluate the effectiveness of adjunctive incoBoNT-A injection combined with triple combination cream (TCC, 4% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide) for treating and preventing melasma recurrence compared to topical therapy alone. A split-face study was conducted in 30 female patients with melasma. One side of the face was randomly applied TCC to the melasma-affected areas for 12 weeks (monotherapy), while the contralateral side received TCC and intradermal incoBoNT-A at baseline and week 12 (combination therapy side). Evaluations were performed at baseline and 2, 4, 8, 12, 16, 20, and 24 weeks. Clinical improvement and melanin index were assessed using the MASI score on the malar area (MASIm), and Colorimeter respectively. Patient satisfaction was also evaluated. Twenty-eight subjects completed the study. The combination therapy side showed significant MASIm decrease at week 2 (p = 0.0032), while the monotherapy side showed no significant change. At 4 weeks, a greater reduction of MASIm was observed in the combination therapy side (MASIm 14.5 and 11.54, 20.41% reduction) when compared to the monotherapy side (MASIm 11.68 and 11.79, 0.93% worsening). At week 12, worsening of melasma was observed on both sides during the summer period. At week 24 (3 months after discontinuing TCC), MASIm was 14.79 on the monotherapy side (worsen 21.03% from baseline) and 9.14 on the combined technique (36.97% improvement, p = 0.0003). Patients' satisfaction was higher for the combination therapy when compared to the monotherapy at the end of the study (8.92 vs. 7.04, p < 0.0001). No serious adverse events occurred. Intradermal incoBoNT-A injection combined with TCC demonstrated superior efficacy in melasma treatmen
Melasma is a common malady affecting all races with a higher incidence in Hispanics, Middle Eastern, Asians, and African origin females (Fitzpatrick skin phototypes III-V). Women are affected much more often than men. Melasma remains a significant cause of cosmetic morbidity and psychosocial embarrassment affecting quality of life necessitating effective and reliable treatment. Unfortunately, treatment remains unsatisfactory due to limited efficacy, adverse effects, and relapses after stopping treatment. Although chemical peels, laser and light therapies and dermabrasion may have utility, the evidence available for their efficacy is limited and they often cause post-inflammatory hyperpigmentation, particularly in individuals with darker skin types. Medical therapies remain mainstay in the management of melasma. The triple combination, hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% (Triluma, Galderma, Ft. Worth Texas, often modified incorporating different corticosteroids) remains the only US FDA-approved treatment for melasma and is the gold standard due its demonstrated efficacy across ethnicities. Oral tranexamic acid alone or in combination with other modalities has also shown significant efficacy. Several cosmeceuticals and botanical extracts used as skin lightening agents have been demonstrated to be useful. Physical sunscreens containing zinc oxide, iron oxide, titanium dioxide, and silicones provide photoprotective and camouflage effect. We propose that a multimodality approach to the treatment of melasma is the most effective treatment approach. This review is focused on the medical therapies for melasma.