fluocinolone acetonide
Sources réglementaires consultées
Indications approuvées
- Traitement symptomatique des dermatoses sensibles aux corticoïdes chez l’adulte et l’enfant à partir de 1 an, notamment sur les zones pileuses ou visibles.
Contre-indications
Absolues
- Hypersensibilité à la fluocinolone ou à l’un des composants.
- Tuberculose, syphilis, infection bactérienne, virale ou fongique de la zone, rosacée, dermatite périorale, ulcères, plaies, acné ou atrophie cutanée.
Mises en garde cliniques
- Mise en garde majeure · Utiliser la plus petite quantité efficace pendant la durée la plus courte possible. Les grandes surfaces, l’usage prolongé, l’altération de la barrière cutanée et l’occlusion augmentent l’absorption et peuvent provoquer une suppression réversible de l’axe HHS, un syndrome de Cushing, une hyperglycémie ou une glycosurie ; les enfants sont plus sensibles. — CIMA/AEMPS, ficha técnica 50031
- Éviter le contact avec les yeux. Arrêter en cas d’irritation ou de sensibilisation. Traiter toute infection cutanée ; en l’absence de réponse rapide, arrêter le corticoïde jusqu’à son contrôle. — CIMA/AEMPS, ficha técnica 50031
- Mise en garde majeure · Éviter l’arrêt brutal après un usage prolongé en raison du risque de rebond. Le psoriasis nécessite une surveillance étroite en raison du risque de rechute, de tolérance, de psoriasis pustuleux ou de toxicité. — CIMA/AEMPS, ficha técnica 50031
Interactions médicamenteuses
- FaibleAutres préparations sur la même zone
Mécanisme: L’application simultanée sur la même zone n’est pas recommandée.
Recommandation: Ne pas appliquer simultanément d’autres préparations sur la zone traitée.
CIMA/AEMPS, ficha técnica 50031https://cima.aemps.es/cima/dochtml/ft/50031/FT_50031.html
Grossesse et allaitement
Éviter pendant le premier trimestre ; ensuite, n’utiliser que si le bénéfice l’emporte sur le risque et éviter les grandes surfaces, l’usage prolongé ou l’occlusion. Pendant l’allaitement, utiliser avec prudence et ne pas appliquer sur les seins.
Bibliographie récente (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.