Pilot study of tolerability and safety of combination product containing terbinafne hydrochloride and econazole nitrate
https://doi.org/10.33667/2078-5631-2022-8-41-46
Abstract
Therapy of onychomycosis today presents a number of diffculties, and the effect does not always meet the expectations of patients.
The purpose of the study. To study the tolerability and safety of the use of the drug Exilac(terbinafne hydrochloride + econazole nitrate), medical nail polish for external use.
Methods. Eighteen volunteers participated in a pilot, prospective, monocentre, open-label tolerability and safety study. The study lasted 6 weeks and consisted of screening and fve visits, at each visit a visual examination, laboratory and instrumental examination methods were performed.
Results. Eighteen healthy volunteers aged 18 to 34 participated in the study. Adverse events associated with the application of the study drug Exilac were observed in 1 (5.56%) volunteer, in the form of signs of delamination of the nail plate of the 1st fnger. This phenomenon is associated with mechanical damage to the nail plate when removing the old layer of the study drug and was regarded as a minor adverse event of mild severity. The remaining adverse events were not related to the use of the drug.
Conclusion. The combined drug Exilac, when used twice daily for 6 weeks, demonstrated a high level of tolerability and safety.
About the Authors
L. S. Kruglova
Central State Medical Academy
Russian Federation
Russian Federation
Kruglova Larisa S., DM Sci (habil.), professor, head of Dept of Dermatovenereology and Cosmetology
SPIN: 1107–4372
A. V. Tamrazova
Central State Medical Academy
Russian Federation
Russian Federation
Tamrazova Anahit V., resident of Dept of Dermatovenerology and Cosmetology
M. A. Turbovskaya
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Turbovskaya Margarita A., 6th year student
A. A. Hotko
Clinical Dermatovenerologic Dispensary
Russian Federation
Russian Federation
Hotko Alkes A., PhD Med, associate professor, deputy chief physician
References
1. Murray S.C., Dawber R.P. Onychomycosis of toenails: orthopaedic and podiatric considerations. Australas J Dermatol. 2002; 43: 105–112.
2. Heikkal H., Stubbs S. The prevalence of onychomycosis in Finland. Br J Dermatol. 1995; 133: 699–701.
3. Elewski B.E., Charif M.A. Prevalence of onychomycosis in patients attending a dermatology clinic in northeastern Ohio for other conditions. Arch Dermatol. 1997; 133: 1172–1173.
4. Roseeuw D. Achilles foot screening project: preliminary results of patients screened by dermatologists. J Eur Acad Dermatol Venerol. 1999; 12: Suppl 1: 6–9.
5. Sergeev A. Yu. Modern ideas about the pathogenesis of onychomycosis. Immunopathology, allergology, infectology. 2000; 1: 101–110.
6. Sergeev Yu.V., Sergeev A. Yu. Etiological approach to the treatment of onychomycosis. Vestn. Dermatol. Venerol. 1998; 2: 68–71.
7. Sergeev A. Yu. Guidelines for the laboratory diagnosis of onychomycosis. Moscow: Geotar-Medicine. 2000: 71–73.
8. Econazole (Econazole): instruction, application and formula. http://www.rlsnet.ru/mnn_index_id_158.htm.
9. Cohen A.D., Medvesovsky E., Shalev R., Biton A., Chetov T., Naimer S., Shai A., Vardy D.A. An Independent Comparison Of Terbinafne And Itraconazole In The Treatment Of Toenail Onychomycosis. J Dermatolog Treat. 2003 Dec; 14 (4): 237–42.
10. Achten G., Wanet R.J. Onychomycosis in the laboratory. Mykosen. 1978; 21:125–127.
11. Terbinafne (Terbinafne): instruction, application and formula. http://www.rlsnet.ru/mnn_index_id_1475.htm
12. US Natl Inst Health; DailyMed. Current Medication Information for Lamisil at Continuous Spray (terbinafne hydrochloride) liquid (July 2011). http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5fc76055-bdfd-4ee7–9d66-fe76f502060f.
13. US Natl Inst Health; DailyMed. Current Medication Information for Econazole nitrate cream [Physicians Total Care, Inc.] (July 2011). http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=050155b7-e8fe-4eee-9516–716399f559f6.
14. Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”, as amended. federal laws dated July 27, 2010 No. 192-FZ, dated October 11, 2010 No. 271-FZ, dated November 29, 2010 No. 313-FZ.
15. Guidelines for conducting clinical trials of drugs. Ed. A.N. Mironov. Moscow: Grif & Co., 2012.
16. Guidelines for the examination of medicines. Moscow: Grif & Co., 2013.
17. Grigoriu D., Grigoriu A. Double-blind comparison of the effcacy, toleration and safety of tioconazole base 1% and econazole nitrate 1% creams in the treatment of patients with fungal infections of the skin or erythrasma. Dermatologica. 1983; 166 Suppl 1: 8–13.
18. Elewski B.E., Ghannoum M.A., Mayser P., Gupta A.K., Korting H.C., Shouey R.J. et al. Effcacy, safety and tolerability of topical terbinafne nail solution in patients with mild-to-moderate toenail onychomycosis: results from three randomized studies using double-blind vehicle-controlled and open-label active-controlled design. Journal of the European Academy of Dermatology and Venereology. 2011; Dec 2011 DOI: 10.1111/j.1468–3083.2011.04373.x.
19. Smith E. B., Stein L. F., Fivenson D.P, Atillasoy E. S. Clinical trial: the safety of terbinafne in patients over the age of 60 years: a multicenter trial in onychomycosis of the feet. Int J Dermatol. 2000 Nov; 39 (11): 861–4. DOI: 10.1046/j.1365–4362.2000.00087–2.x. PMID: 11123452.
20. Nair A.B., Sammeta S.M., Kim H.D., Chakraborty B., Friden P.M., Murthy S.N. Alteration of the Diffusional Barrier Property Of The Nail Leads To Greater Terbinafne Drug Loading And Permeation. Int J Pharm. 2009 Jun 22; 375 (1–2): 22–7.
21. Terbinafne (Terbinafne): instruction, application and formula. http://www.rlsnet.ru/mnn_index_id_1475.htm
Review
For citations:
Kruglova L.S., Tamrazova A.V., Turbovskaya M.A., Hotko A.A. Pilot study of tolerability and safety of combination product containing terbinafne hydrochloride and econazole nitrate. Medical alphabet. 2022;(8):41-46. (In Russ.) https://doi.org/10.33667/2078-5631-2022-8-41-46
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