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.

Autor: Sinha SD; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Rajamma A; Department of Dermatology and Venerology, ACSR Government Medical College, Nellore, Andhra Pradesh, India., Bandi MR; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Sriramadasu SC; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Sahu S; Department of Dermatology, Maharani Laxmi Bai Medical College, Jhansi, Uttar Pradesh, India., Kothiwala RK; Department of Dermatology, Venereology and Leprosy, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan, India., Halder S; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India., Sankerneni A; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Panapakam M; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Vemireddy VNR; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Vattipalli R; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India., Devireddy SR; Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India. srinivasreddy.de@hetero.com.
Jazyk: angličtina
Zdroj: Clinical drug investigation [Clin Drug Investig] 2023 Jul; Vol. 43 (7), pp. 565-574. Date of Electronic Publication: 2023 Jul 18.
DOI: 10.1007/s40261-023-01288-1
Abstrakt: 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.
(© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Databáze: MEDLINE
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