fluocinolone acetonide
Regulatory sources consulted
Approved indications
- Symptomatic treatment of corticosteroid-responsive dermatoses in adults and children from 1 year of age, especially on hairy or visible areas.
Contraindications
Absolute
- Hypersensitivity to fluocinolone or any component.
- Tuberculosis, syphilis, bacterial, viral, or fungal infection of the area, rosacea, perioral dermatitis, ulcers, wounds, acne, or skin atrophy.
Clinical warnings
- Major warning · Use the smallest effective amount for the shortest possible time. Large areas, prolonged use, an impaired skin barrier, and occlusion increase absorption and may cause reversible HPA-axis suppression, Cushing syndrome, hyperglycemia, or glucosuria; children are more susceptible. — CIMA/AEMPS, ficha técnica 50031
- Avoid eye contact. Stop if irritation or sensitization occurs. Treat any skin infection; if it does not respond promptly, stop the corticosteroid until it is controlled. — CIMA/AEMPS, ficha técnica 50031
- Major warning · Avoid abrupt withdrawal after prolonged use because of rebound risk. Psoriasis requires close supervision because of relapse, tolerance, pustular psoriasis, or toxicity. — CIMA/AEMPS, ficha técnica 50031
Drug interactions
- LowOther preparations on the same area
Mechanism: Simultaneous application to the same area is not recommended.
Recommendation: Do not apply other preparations to the treated area at the same time.
CIMA/AEMPS, ficha técnica 50031https://cima.aemps.es/cima/dochtml/ft/50031/FT_50031.html
Pregnancy and lactation
Avoid during the first trimester; thereafter, use only if benefit outweighs risk and avoid large areas, prolonged use, or occlusion. During breastfeeding, use cautiously and do not apply to the breasts.
Recent literature (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.