DOI: http://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20221197

A prospective, post-marketing clinical study to evaluate the effectiveness of luliconazole 1% cream in treating cutaneous mycoses

Suneel Vartak, Anup Petare, Krishna Veligandla, Rahul Rathod, Akhila Paspulate, Amey Mane

Abstract


Background: Superficial (or cutaneous) mycoses are fungal infections that affect the superficial layers of the skin, hair, and nails. Luliconazole is an azole antifungal, used in the treatment of infections caused by fungus and yeast. The objective of the study is to assess the effectiveness and safety of new topical formulation of luliconazole (1% w/w luliconazole with 1% pramoxine added as excipient) in patients with cutaneous mycoses.

Methods: Patients with cutaneous mycoses aged 18 years and older were included in the post-marketing open-label, monocentric, prospective study. Effectiveness was assessed on patients prescribed with new 1% w/w luliconazole cream. The primary endpoint was a change in itch severity as assessed on 10-point Visual analogue scale score. The secondary endpoints include the number of patients who achieved all-night relief from itching and the type of adverse events during the treatment. Clinical effectiveness for itching was assessed at different time points after baseline.

Results: The mean itch severity scores at 2 min, 5 min, 10 min, 1 hour, 4 hour, and 8 hour time points were observed on 30 clinically diagnosed patients. A significant reduction of the mean±standard deviation score was observed from 6.82±0.72 at baseline to 3.37±1.68 after 8 hours. About 66.6% of patients achieved all-night relief from itching. There were no adverse events reported by any participant over the study duration.

Conclusions: This new topical formulation of luliconazole (1% w/w) containing 1% pramoxine as excipient significantly reduced itch in cutaneous mycoses with no reported adverse events. Large randomised controlled studies are required to confirm our findings.


Keywords


Cutaneous mycoses, Fungal infection, Luliconazole, Post-marketing study, Topical cream

Full Text:

PDF

References


Dias MF, Quaresma-Santos MV, Bernardes-Filho F, Amorim AG, Schechtman RC, Azulay DR. Update on therapy for superficial mycoses: review article part I. An Bras Dermatol. 2013;88:764-74.

Khodadadi H, Zomorodian K, Nouraei H, Zareshahrabadi Z, Barzegar S, Zare MR et al. Prevalence of superficial‐cutaneous fungal infections in Shiraz, Iran: A five‐year retrospective study (2015–2019). J Clin Lab Anal. 2021;e23850.

Lao M, Wang X, Ding M, Yang Z, Chen H, Liang L et al. Invasive fungal disease in patients with systemic lupus erythematosus from Southern China: a retrospective study. Lupus. 2019;28(1):77-85.

Deshmukh SG, Thakre T, Gupta J, Waskar R. A Case Study on Management of Tinea Cruris with Classical Vaman Karma. J Pharm Res Int. 2021;33(33B):195-202.

Otašević S, Momčilović S, Golubović M, Ignjatović A, Rančić N, Đorđević M et al. Species distribution and epidemiological characteristics of superficial fungal infections in Southeastern Serbia. Mycoses. 2019;62(5):458-65.

Pappas PG, Rex JH, Sobel JD, Filler SG, Dismukes WE, Walsh TJ et al. Guidelines for treatment of candidiasis. Clin Infect Dis. 2004;38(2):161-89.

Gupta AK, Sauder DN, Shear NH. Antifungal agents: an overview. Part I. J Am Acad Dermatol. 1994;30:677-98.

Borgers M. Mechanism of action of antifungal drugs, with special reference to the imidazole derivatives. Rev Infect Dis. 1980;2:520-34.

Khanna D, Bharti S. Luliconazole for the treatment of fungal infections: An evidence-based review. Core Evid. 2014;9:113-24.

Burstein VL, Beccacece I, Guasconi L, Mena CJ, Cervi L, Chiapello LS. Skin immunity to dermatophytes: From experimental infection models to human disease. Front Immunol. 2020;11:605644.

Hazarika D, Jahan N, Sharma A. Changing trend of superficial mycoses with increasing nondermatophytemold infection: A clinicomycological study at a tertiary referral center in Assam. Indian J Dermatol. 2019; 64(4):261-5.

Hay R. Superficial fungal infections. Medicine. 2013;41:716-8.

Kyle AA, Dahl MV. Topical therapy for fungal infections. Am J Clin Dermatol. 2004;5:443-51.

Rajagopalan M, Inamadar A, Mittal A, Miskeen AK, Srinivas CR, Sardana K et al. Expert consensus on the management of dermatophytosis in India (ECTODERM India). BMC Dermatol. 2018;18:6.

Joise P, Jennet P. Disregarded misuse of irrational corticosteroid cocktails and recalcitrant fungal infections. Int J Curr Res. 2020;12(01):9224-7.

Naaz R, Chand S, Nandakumar UP, Vinay BC, KC BR, Shetty S. Prospective observational study on prescribing pattern of antifungal drugs in the 400 out-patient department of dermatology in a tertiary care hospital. Biomed Pharmacol J. 2021;14(1):311-6.

Kapileshwari GR, Barve AR, Kumar L, Bhide PJ, Joshi M, Shirodkar RK. Novel drug delivery system of luliconazole - Formulation and characterisation. J Drug Deliv Sci Technol. 2020;55:101302.

Jarratt M, Jones T, Kempers S, Rich P, Morton K, Nakamura N et al. Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study. Cutis. 2013;91(4):203-310.

Verma S, Vasani R, Reszke R, Matusiak Ł, Szepietowski JC. Prevalence and clinical characteristics of itch in epidemic-like scenario of dermatophytoses in India: Across-sectional study. J of the European academy of dermatology and venerology. 2020;34(1):180-3.

Kaur M, Gupta A, Mahajan R, Gill M. Efficacy, safety, and cost evaluation of the topical luliconazole therapy versus topical clotrimazole therapy in patients with localized dermatophytosis in a tertiary care hospital: An Observational Study. Int J Appl Basic Med Res. 2020;10(4):260-4.

Alam MS, Misra A, Mishra PK. Efficacy of topical luliconazole in management of tinea corporis and tinea cruris infections. IJHCR. 2020;3(8):89-92.

Gold MH, Olin JT. Once-daily luliconazole cream 1% for the treatment of interdigital tinea pedis. Expert Rev Anti Infect Ther. 2015;13(12):1433-40.

Gupta AK, Kohli Y. Evaluation of in vitro resistance in patients with onychomycosis who fail antifungal therapy. Dermatology. 2003;207:375-80.

He A, Kwatra SG, Sharma D, Matsuda KM. The role of topical anesthetics in the management of chronic pruritus. J Dermatolog Treat. 2017;28(4):338-41.

Zirwas MJ, Barkovic S. Anti-Pruritic Efficacy of Itch Relief Lotion and Cream in Patients With Atopic History: Comparison With Hydrocortisone Cream. J Drugs Dermatol. 2017;16(3):243-7.

Dawn A, Yosipovitch G. Treating itch in psoriasis. Dermatol Nurs. 2006;18:227-33.

Grove G, Zerweck C. An evaluation of the moisturizing and anti-itch effects of a lactic acid and pramoxine hydrochloride cream. Cutis. 2004;73:135-9.

Khopkar U, Barua S, Rathi SK, Tiwari AN, Nikam B, Nayek C et al. Pramoxine containing topical formulation of eberconazole in the management of dermatophytosis in India: a consensus statement. Int J Res Dermatol. 2022;8:175-84.

Young TA, Patel TS, Camacho F, Clark A, Freedman BI, Kaur M et al. A pramoxine-based anti-itch lotion is more effective than a controllotion for the treatment of uremic pruritus in adult hemodialysispatients. J Dermatol Treat. 2009;20:76-81.

Patel T, Yosipovitch G. Therapy of pruritus. Expert OpinPharmacother. 2010;11:1673-82.

Kircik LH. Efficacy and onset of action of hydrocortisone acetate 2.5% and pramoxine hydrochloride 1% lotion for the management of pruritus: Results of a pilot study. J Clin Aesthet Dermatol 2011;4:48-50.