Clinical drug investigation · 2023
Efficacy and Safety of Naftifine Hydrochloride 2% Gel in Interdigital Tinea Pedis: A Phase III Randomised, Double-Blind, Parallel-Group, Active-Controlled Study in Indian Adult Patients.
Рандомизированное исследованиеКлиническое исследование III фазыСтатьяНазвание и аннотация: Перевод в очереди
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Sinha Shubhadeep D, Rajamma Avula, Bandi Mohan Reddy, Sriramadasu Sreenivasa Chary, Sahu Suvash, Kothiwala Raj Kumar, Halder Saswati, Sankerneni Abhilash, Panapakam Muralidhar, Vemireddy Venkata Narayana Reddy, Vattipalli Ramya, Devireddy Srinivas Reddy
Аннотация
BACKGROUND AND OBJECTIVE: Naftifine, an allylamine, is highly effective against tinea pedis and exhibits relatively greater affinity to skin and nail beds, possibly due to its high lipophilicity. To study the efficacy and safety of naftifine 2% gel in an Indian population, a phase III multicentre double-blind, comparative, parallel-group study was conducted in comparison with miconazole 2% gel in patients with interdigital tinea pedis, with mild to moderate symptoms.
PATIENTS AND METHODS: Patients presenting with mild to moderate signs and symptoms of interdigital tinea pedis and mycologically confirmed tinea infection were randomised to either naftifine hydrochloride 2% gel (n = 112) or miconazole 2% gel (n = 112) in 1:1 ratio. All patients were treated for 2 weeks with a follow-up of up to 12 weeks. Study evaluations were done at the end of 2, 6, and 12 weeks. The primary efficacy endpoint was the proportion of patients achieving clinical cure at week 6 (± 4 days) and secondary endpoints were the mycological cure at week 6 and week 12 and complete cure at week 12.
RESULTS: At the end of week 6, clinical cure was 54.55% and 50.00% in the naftifine and miconazole groups (p = 0.4960), respectively, and it was increased to 78.18% and 76.36% in the naftifine and miconazole group (p = 0.7455) at the end of week 12. Mycological and clinical cure were similar in the naftifine and miconazole groups at week 6 and week 12. The safety and tolerability profiles of both treatments were similar.
CONCLUSIONS: Naftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel.
TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2021/01/030753.
PATIENTS AND METHODS: Patients presenting with mild to moderate signs and symptoms of interdigital tinea pedis and mycologically confirmed tinea infection were randomised to either naftifine hydrochloride 2% gel (n = 112) or miconazole 2% gel (n = 112) in 1:1 ratio. All patients were treated for 2 weeks with a follow-up of up to 12 weeks. Study evaluations were done at the end of 2, 6, and 12 weeks. The primary efficacy endpoint was the proportion of patients achieving clinical cure at week 6 (± 4 days) and secondary endpoints were the mycological cure at week 6 and week 12 and complete cure at week 12.
RESULTS: At the end of week 6, clinical cure was 54.55% and 50.00% in the naftifine and miconazole groups (p = 0.4960), respectively, and it was increased to 78.18% and 76.36% in the naftifine and miconazole group (p = 0.7455) at the end of week 12. Mycological and clinical cure were similar in the naftifine and miconazole groups at week 6 and week 12. The safety and tolerability profiles of both treatments were similar.
CONCLUSIONS: Naftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel.
TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2021/01/030753.