luliconazole
Sources réglementaires consultées
Indications approuvées
- Teigne interdigitale du pied, teigne inguinale et teigne corporelle dues à des organismes sensibles.
Mises en garde cliniques
- Usage topique uniquement ; ne pas utiliser par voie orale, ophtalmique ou intravaginale. — openFDA Luliconazole cream 1% set ID 7ccda3ba-9c98-468d-83c6-7f0cc7c88c33
Interactions médicamenteuses
- ModéréeSubstrats sensibles du CYP2C19
Mécanisme: Le luliconazole topique est généralement un inhibiteur faible du CYP2C19. Chez certains adolescents traités pour une tinea cruris, l’exposition systémique peut approcher ou dépasser le niveau requis pour une inhibition modérée du CYP2C19.
Recommandation: Surveiller la réponse clinique et les effets indésirables du substrat sensible du CYP2C19 ; aucun ajustement empirique de dose n’est établi sans information propre au substrat.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1c68d6f4-2733-4b96-816c-7339f021e1b8
Effets indésirables
Communs (≥1%)
Réactions au site d’application (moins de 1 %)
Rares mais graves
Dermatite de contact ou cellulite après commercialisation
Grossesse et allaitement
Les données humaines sont insuffisantes ; évaluer le besoin clinique. Pendant l’allaitement, mettre en balance ses bénéfices, le besoin clinique maternel et les effets possibles chez le nourrisson.
Bibliographie récente (PubMed)
Dermatophytomas are characterized as a hyperkeratotic fungal mass in the subungual space, showing as dense white or yellow, typically in longitudinal streaks or patches. Masses can be visualized by traditional microscopy or histology. Newer technologies such as dermoscopy and optical coherence tomography also provide visual features for dermatophytoma diagnosis. The density of fungal mass, and lack of adherence to the nail structures, as well as possible biofilm development, may play a role in the reduction in drug penetration and subsequent lack of efficacy with traditional oral therapies such as terbinafine and itraconazole. A combination of drug treatment with mechanical or chemical debridement/avulsion has been recommended to increase efficacy. The topical antifungal solutions such as tavaborole, efinaconazole, and luliconazole may reach the dermatophytoma by both the transungual and subungual routes, due to low affinity for keratin and low surface tension. Current data indicates these topicals may provide efficacy for dermatophytoma treatment without debridement/avulsion. Similarly, fosravuconazole (F-RVCZ) has an improved pharmacological profile versus ravuconazole and may be an improved treatment option versus traditional oral therapies. The availability of improved treatments for dermatophytomas is crucial, as resistance to traditional therapies is on the increase.
Onychomycosis is a common nail disease caused by fungi. The primary pathogens are dermatophytes; however, yeasts, non-dermatophyte moulds, and mixed fungal populations may also contribute to the development of a recalcitrant condition, usually accompanied by difficulties in everyday life and severe emotional stress. Treatment failure and relapse of the infection are the most frequent problems, though new issues have become the new challenges in the therapeutic approach to onychomycosis. Resistance to antifungals, an increasing number of comorbidities, and polydrug use among the ageing population are imperatives that impose a shift to safer drugs. Topical antifungals are considered less toxic and minimally interact with other drugs. The development of new topical drugs for onychomycosis is driven by the unmet need for effective agents with prolonged post-treatment disease-free time and a lack of systemic impact on the patients' health. Efinaconazole, Tavaborole, and Luliconazole have been added to physicians' weaponry during the last decade, though launched on the market of a limited number of countries. The pipeline is either developing new products (e.g., ME-1111 and NP213) with an appealing combination of pharmacokinetic, efficacy, and safety properties or reformulating old, well-known drugs (Terbinafine and Amphotericin B) by using new excipients as penetration enhancers.
Luliconazole is an imidazole agent, used for the treatment of fungi infection, especially dermatophytes. The mechanism of action of the drug consisting in inhibits sterol 14α-demethylase which interferes with ergosterol biosynthesis. Due to low aqueous solubility and highly lipophilic, there is a need to develop drug delivery systems (nanocarriers) capable to increase the solubility, permeability, and skin retention of luliconazole, and promote a better therapeutic effect. In this context, this review presents characteristics, properties, nanocarriers, and analytical methods used for luliconazole. From the analyzed studies, the majority reports the use of RP-HPLC techniques for luliconazole determination, but also are cited spectrophotometric UV methods. The luliconazole has been qualitatively and quantitatively analyzed in different matrices, such as raw material and pharmaceutical formulations, however, in this review, only one study was found with the luliconazole quantification biological matrix, demonstrating the lack of studies related to the quantification of the drug in biological matrices. The drug quantification in different matrices by analytical methods is of great importance since they assist in the control of the quality, efficacy, and safety of the medicine.
The routine options for onychomycosis are oral, topical, and device-based therapies which are often limited in terms of efficacy and unsatisfactory side effects. Topical agents such as luliconazole, tioconazole, terbinafine, and tazarotene can be more effective when combined with laser therapies. Our aim was to compare the efficacy and satisfaction rates of CO2 laser therapy with topical agents in patients with onychomycosis. PubMed, the Cochrane Library, Embase, and Ovid databases were searched to identify randomized controlled trials (RCTs) evaluating the effects of combined therapies. Selected study data were analyzed for differences expressed as odds ratio (OR) and relative ratio (RR) with 95% confidence intervals (CI) for dichotomous outcomes. Efficacy and satisfaction outcomes were assessed using quantitative methods. Our investigations showed that combined CO2 laser and topical treatments significantly increased efficacy 5.38-fold when compared with topical agents alone (OR 5.38; 95% CI; 3.20-9.04; p < 0.00001), with low heterogeneity observed among studies (I2 = 38%). Mycological clearance comparison rates were also improved by combined treatments. The higher satisfaction of the combined group was assessed by pooled effect (OR 4.56; 95% CI; 2.78-7.49; p < 0.00001). Our evidence suggests combined therapy may exert positive effects and satisfactory safety for patients with moderate to severe onychomycosis, however, optimal combination options and appropriate dosages require more comprehensive RCTs.
Dermatophytosis is a common superficial fungal infection that is increasingly complicated by terbinafine (TRB)-resistant strains, especially Trichophyton indotineae. Conventional antifungals often show limited efficacy against resistant isolates, highlighting the need for novel treatments. This study evaluated the efficacy and safety of nanostructured lipid carrier-loaded luliconazole (NLC-LCZ) gel in TRB-resistant dermatophytosis. In a randomized, clinical trial conducted at Touba Specialty Clinic, Sari, Iran, forty-eight adults with confirmed TRB-resistant dermatophytosis were assigned to oral itraconazole (ITZ), topical luliconazole, NLC-LCZ gel, or ITZ + NLC-LCZ gel for 4 weeks (n = 12 each). The primary endpoint was complete recovery (clinical and mycological), while secondary endpoints included lesion size, itch, inflammation, Dermatology Life Quality Index (DLQI), and safety. Complete recovery occurred in 83.3% of ITZ + NLC-LCZ, 75% of NLC-LCZ, 58.3% of LCZ, and 0% of ITZ alone. LCZ and NLC-LCZ had lower MIC50/ MIC90 values (0.016 μg/mL) compared with ITZ (MIC90: 8 μg/mL) and TRB (MIC90: 4 μg/mL). DLQI improved most in NLC-LCZ (score: 2) and ITZ + NLC-LCZ (score: 3) groups (p < 0.001). Adverse events were mild and did not require discontinuation. These findings indicate that NLC-LCZ enhanced antifungal efficacy and quality of life in TRB-resistant dermatophytosis, and that combination therapy with ITZ + NLC-LCZ yielded the highest recovery, representing a promising strategy against resistant infections.