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.

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 post-treatment 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.

Interdepartmental Dermatology: Characteristics and Impact of Dermatology Inpatient Referrals at a Teaching Hospital in Eastern India.

BACKGROUND: Dermatology is primarily considered to be an outpatient-centered specialty. However, several inpatient admissions to other specialties require dermatologic consultation for optimum management. AIMS: To analyze the causes of inpatient dermatology referrals, departments sending referrals, and impact of dermatology consultation on patient management. MATERIALS AND METHODS: We conducted a cross-sectional study by analyzing the records of 486 patient referrals over a 4-year period. The demographic details, specialties requesting consultation, cause of referral, and dermatological advice have been recorded and analyzed. RESULTS: Dermatology consultation changed the dermatologic diagnosis and treatment of almost two-thirds of patients. General medicine requested the maximum number of referrals, "skin rash" being the most common cause for referral. Accurate diagnosis on referrals was provided by only 30.2% of nondermatologists. Common dermatological disorders were often misdiagnosed by these physicians, and dermatology referrals had significant impact on the diagnosis and subsequent management of these patients. CONCLUSION: While dermatologic referral leads to improved patient care, there is a need for better training of nondermatologists enabling them to recognize and treat common dermatoses.