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Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study

OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open–label, p...

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Autores principales: Dakhale, Ganesh N., Gupta, Ashish V., Mukhi, Jayesh I., Kalikar, Mrunalini V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8525790/
https://www.ncbi.nlm.nih.gov/pubmed/34760651
http://dx.doi.org/10.4103/picr.PICR_24_19
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author Dakhale, Ganesh N.
Gupta, Ashish V.
Mukhi, Jayesh I.
Kalikar, Mrunalini V.
author_facet Dakhale, Ganesh N.
Gupta, Ashish V.
Mukhi, Jayesh I.
Kalikar, Mrunalini V.
author_sort Dakhale, Ganesh N.
collection PubMed
description OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open–label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. RESULTS: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. CONCLUSION: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.
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spelling pubmed-85257902021-11-09 Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study Dakhale, Ganesh N. Gupta, Ashish V. Mukhi, Jayesh I. Kalikar, Mrunalini V. Perspect Clin Res Original Article OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open–label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. RESULTS: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. CONCLUSION: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole. Wolters Kluwer - Medknow 2021 2021-01-08 /pmc/articles/PMC8525790/ /pubmed/34760651 http://dx.doi.org/10.4103/picr.PICR_24_19 Text en Copyright: © 2021 Perspectives in Clinical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Original Article
Dakhale, Ganesh N.
Gupta, Ashish V.
Mukhi, Jayesh I.
Kalikar, Mrunalini V.
Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title_full Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title_fullStr Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title_full_unstemmed Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title_short Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study
title_sort comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: a prospective, randomized, open-label study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8525790/
https://www.ncbi.nlm.nih.gov/pubmed/34760651
http://dx.doi.org/10.4103/picr.PICR_24_19
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