Sertaconazole versus Clotrimazole and Miconazole Creams in the Treatment of Otomycosis: A Placebo-Controlled Clinical Trial

Document Type : Original

Authors

Otorhinolaryngology Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.

Abstract

Introduction:
Fungal otitis extern or otomycosis, is common worldwide, and resistance of fungal organisms to antifungal drugs has been reported in otomycosis and other fungal infections. This study aimed to evaluate the clinical efficacy of sertaconazole versus placebo, as well as miconazole and clotrimazole topical creams in otomycosis patients.
 
Materials and Methods:
In this double-blinded clinical trial, 138 otomycosis patients (230 ears) were evaluated in four groups. After the first session of the ear canal debridement and irrigation with acetic acid 2% solution, the patients were treated with either A) sertaconazole 2% cream, B) miconazole 2% cream, C) clotrimazole 2% cream, or D) placebo. The results of clinical evaluations and response to treatment (complete, partial, and no response) were recorded at the time of the first visit and by the end of the first, second, and fourth weeks of treatment. A p-value less than 0.05 was considered statistically significant.
 
Results:
Response results to treatments, ear itching, aural fullness, otalgia, and otorrhea revealed significant differences in either group A or groups B and C, compared to the placebo group (P<0.05). Considering both complete and partial responses together, the sertaconazole group showed a 96.43% response rate. For complete response, miconazole revealed better results, compared to the other two creams; however, the differences for the therapeutic outcomes were not statistically significant. No adverse reactions were observed in the study groups.
Conclusions:
Sertaconazole had comparable results with miconazole and clotrimazole in the treatment of otomycosis, and especially if complete and partial responses were considered together, it was more efficacious than miconazole and clotrimazole creams.

Keywords


  1. Munguia R, Daniel SJ. Ototopical antifungals and otomycosis: a review.Int J Pediatr Otorhinolaryngol. 2008;72:453-9.
  2. Pradhan B, Tuladhar NR, Amatya RM.Prevalence of otomycosis in outpatient department of otolaryngology in Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Ann Otol Rhinol Laryngol. 2003;112:384-7.
  3. Yavada s, Gulica J. Role of ototopical fluconazole and clotrimazole in management of otomycosis. Indian J Otolaryngol. 2007; 13: 12-5.
  4. Ologe FE, Nwabuisi C. Treatment outcome of otomycosis in Ilorin, Nigeria. West Afr J Med. 2002;21:34-6.
  5. Nemati S, Hassanzadeh R, KhajehJahromi S, Delkhosh Nasrollah Abadi A. Otomycosis in the north of Iran: common pathogens and resistance to antifungal agents. Eur Arch Otorhinolaryngol. 2014; 271:953–7.
  6. Zaror L, Fischman O, Suzuki FA, Felipe RG. Otomycosis in São Paulo. Rev Inst Med Trop São Paulo. 1991; 33:169-73.
  7. Shuai Xu, Jianfeng Li, Ling Ding, Kun Ga, FengyangXie, Jie Han, et al. Efficacy and safety of Terbinafine Hydrochloride spray and 3% Boric Acid Alcohol Ear Drops in Otomycosis. Acta Otolaryngol. 2020; 140:302-6.
  8. Ho T, Vrabec JT, Yoo D, Coker NJ. Otomycosis: clinical features and treatment implications. Otolaryngol Head Neck Surg. 2006; 135:787-91.
  9. Yehia MM, Al-Habib HM, Shehab NM. Otomycosis: a common problem in North Iraq. J Laryngol Otol. 1990; 104:387-93.

 

  1. Ozcan KM, Ozcan M, Karaarslan A, Karaarslan F. Otomycosis in Turkey: predisposing factors, aetiology and therapy. J Laryngol Otol. 2003; 117:39-42.
  2. Kiakojuri K, Hasanjani Roushan M, Sepidgar SA. Suction clearance and 2% topical miconazole versus the same combination with acidic drops in the treatment of otomycosis. Southeast Asian J Trop Med Public Health. 2007; 38:749-53.
  3. Alnawaiseh S, Almomani O, Alassaf S, Elessis A, Shawakfeh N, Altubeshi Kh, et al. Treatment of Otomycosis: A comparative Study Using Miconazole Cream with Clotrimazole Otic Drops. J Royal Med Serv. 2011;18: 34-7.
  4. Satish HS, ViswanathaB, ManjuladeviM. A Clinical Study of Otomycosis. IOSR Journal of Dental and Medical Sciences (IOSR-JDMS). 2013;5: 57-62.
  5. Pontes ZBVDS, Silva ADF, Lima EDO, Guerra MDH, Oliveira NMC, Carvalho MDFFP, et al. Otomycosis: a retrospective study. Braz Otorhinolaryngol. 2009; 75:367–70.
  6. Mahmoudabadi AZ, Najafyan M, Alidadi M. Clinical study of Candida vaginitis in Ahvaz, Iran and susceptibility of agents to topical antifungal. Pak J Med Sci. 2010; 26:607-10.
  7. Jamie D, Croxtall D, Plosker GL. Sertaconazole, A Review of Its Use in the Management of Superficial Mycoses in Dermatology and Gynaecology. Drugs 2009; 69:339-59.
  8. Kaur C, Kaur N, Sharma D, Singh G, Singh N, Singh SK, Singh V, Kumar R. An updated review of what, when and how of sertaconazole: A potent antifungal agent. Research Journal of Pharmacy and Technology. 2021 Jun 1;14(6):3441-8.
  9. Sumbria D, Yousuf A, Ahmad R. Hospital based study on ethiopathogenesis and treatment of otomycosis: ethnic Kashmiri population. Int J otolaryngol Head and Neck surg.2019;5: 1190-6.
  10. Moharram AM, Ahmed HE and Nasr S. Otomycosis in Assiut, Egypt. J Basic Appl Mycol Egypt. 2013; 4:1-11.
  11. Kinneri Mehta, Daniel J. Lee, Daniel S. Roberts, Topical Therapies of External Ear Disorders In: Flint PW, Haughey BH, Robbins KT et al (editors) Cummings Otolaryngology-head and neck surgery, 7th Amsterdam, Netherlands: Elsevier Health Sciences; 2020: 2101-08.
  12. Alirezaei P, Jiryaee N, ShabbakA. Comparison of Efficacy of Clotrimazole 1% Cream with Sertaconazole 2% Cream in Treatment of Adult Seborrheic Dermatitis. Avicenna J Clin Med. 2019; 26: 67-74.