To Compare the Efficacy of Once a Day Versus Twice Daily Application of Amorolfine 0.25% Cream- A Single-Blinded, Randomized, Control Study

Lade, Nitin; Pathrabe, Neha; Morey, P. Mas

doi:10.14260/jemds/2017/1360

Cited by 1 publication

(1 citation statement)

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“…Several clinical studies conducted in the mentioned medical conditions have consistently demonstrated the safety and efficacy of amorolfine in both topical cream and nail lacquer forms. Specifically, multiple trials have highlighted the impressive effectiveness of amorolfine 0.25% w/w cream in treating dermatophytosis patients, achieving higher rates of both clinical and mycological cure [8,[11][12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Amorolfine Lotion 0.25% w/v Compared to Amorolfine Cream 0.25% w/w in Patients With Superficial Fungal Infections of the Skin: A Multi-center, Randomized, Open-Label, Active-Controlled, Non-inferiority Phase III Clinical Trial

Rao,

Siddananjappa,

Sidana

et al. 2024

Cureus

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Background: Dermatophytosis, a major cause of superficial fungal infections, requires topical and systemic antifungals. Amorolfine, a morpholine derivative, is a new topical antifungal available in cream and lotion formulations.Objective: To evaluate the efficacy and safety of amorolfine lotion 0.25% compared to amorolfine cream 0.25% in patients with dermatophytosis.Methods: A multi-center randomized, two-arm, active-controlled, parallel, non-inferiority phase III clinical trial involving 284 dermatophytosis patients was conducted, with the test arm using amorolfine lotion and the reference arm using amorolfine cream. The study drugs were applied once daily in the evening for four weeks and patients were followed up for another two weeks. The primary endpoint was clinical cure, while secondary endpoints included mycological cure, composite cure, global efficacy assessment, and posttreatment relapse. Safety and tolerability were assessed.Results: Amongst the enrolled patients, 69.9% and 68.1% of patients had tinea corporis, while 30.1% and 31.9% had tinea cruris. The majority of patients in both groups (99.3% test and 97% reference) achieved a clinical cure at the end of treatment. Mycological cure was achieved by 98.6% and 96.3% respectively. A composite cure was achieved by 98.6% in the test arm versus 96.3% in the reference arm. A total of two AEs were reported in two (1.4%) patients in the test group and three AEs were reported in three (2.1%) patients in the reference group, all of the AEs were mild and resolved within three days without supportive medication. No severe adverse effects were reported in any of the study subjects.Conclusion: Amorolfine lotion 0.25% w/v showed a non-inferior clinical, mycological, and composite cure in dermatophytosis patients, was well-tolerated, and had a similar safety profile to amorolfine cream 0.25% w/w.

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