fluocinonide
Regulatory sources consulted
Approved indications
- Acute exogenous or endogenous eczema, seborrheic eczema, and adjunctive treatment of psoriasis.
Contraindications
Absolute
- Hypersensitivity to fluocinonide or any component.
- Cutaneous tuberculosis or syphilis, viral, bacterial, or fungal infection, rosacea, perioral dermatitis, ulcer, acne, skin atrophy, ocular use, or deep wounds.
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 54036
- 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 54036
- Do not apply to intertriginous areas, large surfaces, or under occlusion. Use cautiously with impaired circulation because of ulceration risk. — CIMA/AEMPS, ficha técnica 54036
Pregnancy and lactation
Avoid during the first trimester; thereafter, use only if benefit justifies risk and avoid large areas, prolonged use, or occlusion. Do not apply to the breast during breastfeeding.
Recent literature (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.