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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

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Abstract

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.

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Acknowledgements

The authors would like to thank Hetero naftifine investigator group (Dr. G. Narsimha Rao Netha, Gandhi Hospital, Hyderabad; Dr. Devendra Kumar Omer, Nirmal Hospital, Jhansi; Dr. Bindiya Bansal, Maharaja Agrasen Super Specialty Hospital, Jaipur; Dr. Surendra Kumar, SMS Medical College and Hospital, Jaipur; Dr. Gaurav Patel, Hi Tech Multispecialty Hospital, Gandhinagar; Dr. Neha Sharma, Lotus Multispecialty Hospital, Ahmedabad; Dr. Neetu Sidana, Apex Hospitals, Jaipur and Dr. Rinkesh Dobariya, Global Hospital, Surat) for conducting this study. The authors would also like to thank all the study subjects for their valuable participation in this study, and the dedicated physicians, nurses, scientists and staff at each study site for their dedication and outstanding performance of clinical and laboratory study activities. Additionally, we would also like to thank Sudeshna Roy, Hetero Labs Limited, Hyderabad, for all editorial and submission support of our article.

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Authors and Affiliations

  1. Department of Clinical Development & Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India

    Shubhadeep D. Sinha, Mohan Reddy Bandi, Sreenivasa Chary Sriramadasu, Abhilash Sankerneni, Muralidhar Panapakam, Venkata Narayana Reddy Vemireddy, Ramya Vattipalli & Srinivas Reddy Devireddy

  2. Department of Dermatology and Venerology, ACSR Government Medical College, Nellore, Andhra Pradesh, India

    Avula Rajamma

  3. Department of Dermatology, Maharani Laxmi Bai Medical College, Jhansi, Uttar Pradesh, India

    Suvash Sahu

  4. Department of Dermatology, Venereology and Leprosy, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan, India

    Raj Kumar Kothiwala

  5. Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India

    Saswati Halder

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  1. Shubhadeep D. Sinha
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Corresponding author

Correspondence to Srinivas Reddy Devireddy.

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Funding

Funding for this study was provided by Hetero Labs Limited, Hyderabad, India.

Conflicts of Interest

Shubhadeep D. Sinha, Mohan Reddy Bandi, Sreenivasa Chary Sriramadasu, Abhilash Sankerneni, Muralidher Panapakam, Venkata Narayana Reddy Vemireddy and Srinivas Reddy Devireddy are the employees of Hetero Labs Limited. Ramya Vattipalli is a former employee of Hetero Labs Limited. All other authors have no conflict of interest to declare.

Availability of data and material

The data supporting the results reported in the article, which are not available in the article, are available on request if appropriate.

Ethics Approval

This study was conducted after approval by the institutional review board/ethics committee at each participating site (Supplementary Material) and in accordance with good clinical practice (GCP) guidelines issued by the Central Drugs Standard Control Organization (CDSCO), New Drugs and Clinical Trials Rules (2019), Indian Council of Medical Research (ICMR) and ethical guidelines for biomedical research on human patients. This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki (2013), that are consistent with GCP in accordance with International Conference on Harmonization guidelines (ICH-GCP E6), the applicable regulatory requirements, and applicable standard operating procedures (SOPs).

Consent to Participate

All patients signed written informed consent prior to the initiation of study-related procedures for screening.

Consent for Publication

Not Applicable.

Code Availability

Not Applicable.

Author Contributions

Conceptualisation: SDS and SCS; Methodology: SCS and AS; Formal analysis and investigation: AR, RKK, S.S, SH, MP, VNRV and MRB; Writing—original draft preparation: SRD; Writing—review and editing: SCS, SRD, SDS; Supervision: SDS, SCS, and MRB.

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Sinha, S.D., Rajamma, A., Bandi, M.R. et al. 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. Clin Drug Investig 43, 565–574 (2023). https://doi.org/10.1007/s40261-023-01288-1

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