Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial
Phase: PHASE1
Conditions: Otomycosis
Sponsor: Rawalpindi Medical College



Date 16-5-2023 
Department of Rawalpindi Medical University and Allied Hospitals, 
Rawalpindi 
Efficacy Of Pyodine Soaked Gelfoam Vs Single Topical Application Of 
Clotrimazole In Treatment Of Otomycosis: A Randomized Controlled Clinical 
Trial 
Otomycosis is the fungal infection of external auditory canal and is commonly encountered disease 
in ENT clinics constituting almost 30% of ear infections.1 There are multiple contributing factors 
for this condition like humid climate, poor hygiene, self cleaning with multiple objects, use of 
broad spectrum antibiotics, steroids, immunocompromised states and metastatic disease. Mostly 
patients present with itching, aural fullness. Clinical examination show Fungal Hyphae on 
otoscopy. Candida albicans and Aspergillus fumigatus are most commonly involved in 
otomycosis.2 Treatment of otomycosis include local cleaning, discontinuation of topical 
antibiotics, antifungal agents and improvement of health and hygiene of the patients. Multiple 
treatment options are available for treatment of otomycosis but recurrence rate of the disease is 
high. 
A study was conducted by JweryAK and efficacy of clotrimazole, acetic acid and povidine iodine 
was compared in patients with otomycosis and it was concluded  that 97.5% patients of 
Clotrimazole group, 72.5% of acetic acid group and 52.5% of povidine iodine group showed 
response to the treatment option with p value of 0.00001.3 Haq et al in a study suggested that use 
of clotrimazole in management of otomycosis not only relieves its symptoms but also reduces the 
chances of recurrent disease.4  As repeated daily application is difficult for the patients and results 
in reduced compliance so single dose application was studied.In a study conducted by Chavan et 
al single dose topical application of clotrimazole was done and 91.0% patients recovered at the 
end of 1st month with 9.0% having persistent disease.5Another study conducted by Swain et al 
compared  topical use of clotrimazole and povidine iodine solution  for recurrent otomycosis. 
Results showed 40.90% symptoms resolution in clotrimazole group as compared to 81.81% 
resolution in pyodine group with p value 0.0045.6 Mofatteh, et al. conducted a study on 204 patients 
with otomycosis and compared the recovery rates between topical betadine (povidoneiodine) and 
clotrimazole. Authors reported the efficacy of betadine and clotrimazole was the same for the 
treatment of otomycosis.7 
Due to reduced compliance of the patients and ineffective technique of using topical antifungal 
otomycosis has high rate of treatment failure and recurrence. Topical clotrimazole drops and 
povidine iodine solution have been compared for their efficacy in the past but single topical 
application has not been compared until now. If results are in favor of this treatment option it is 
convenient and cost effective. It does not requires patient compliance and numerous visits for local 
clinic. So it will be highly beneficial for the patient 
 

OBJECTIVE:  
To compare the efficacy of pyodine soaked gelfoam with single application of clotrimazole in 
otomycosis  
 
HYPOTHESIS 
Pyodine soaked gelfoam is more effective treatment option for otomycosis as compared to clotrimazole 
topical application  
 
 
OPERATIONAL DEFINITIONS 
 
Otomycosis  
Fungal infection of external ear Canal confirmed on the basis of history and otoscopic observation 
of Hyphae  
 
Treatment response 
• Complete Recovery  
EAC clean with no Fungal Hyphae and return of EAC to its natural state with relief of 
symptoms no tragal tenderness, erythema of EAC  
• Good Response: 
Dry EAC and decrease in discharge and spores 
• Partial Response: 
Slight discharge/ spores but not completely dry EAC 
• No Response:  
Hyper secretions in EAC 
 
 
MATERIALS & METHODS: 
 
Study design:  
Randomized control trial 
 
Study duration: 
 Minimum of 6 months from approval of synopsis 
 
Settings: 
 Department of ENT, Benazir Bhutto Hospital Rawalpindi 
 
Sampling technique: 
 Non probability, consecutive sampling 

 
Sample Size:  
Calculated via open epi Version 3 
Two sided significance level 1-𝛼 =95  
Power of test (%) 1 − 𝛽 =80  
Ratio of sample size =1 
Percentage of clotrimazole with outcome: 41% 
Percent of pyodine soaked solution with outcome=81.81% 
Odds Ratio=6.5 
Risk/prevalence ratio= 2 
Risk or prevalence difference=41 
Sample size clotrimazole group=26 
Sample size pyodine group=26 
 
SAMPLE SELECTION 
 
Inclusion Criteria: 
• 
Clinically diagnosed otomycosis with intact tympanic membrane 
 
Exclusion Criteria: 
• 
Patients with Active Mucosal COM 
• 
Other external auditory Canal abnormalities  
• 
Patient having hearing aid 
 
DATA COLLECTION PROCEDURE: 
After approval from Research and Ethical Committee, Rawalpindi Medical University, Study will 
be carried out in the ENT department Benazir Bhutto Hospital Rawalpindi. Written informed 
consent will be taken from the patients for inclusion in the study. The sample size calculated is 52 
patients. Individuals with a clinical otomycosis diagnosis will recruited for the study. Individuals 
with active CSOM, external auditory canal abnormalities, and hearing aids will be excluded from 
the study. Patients will be enrolled in two treatment groups. Complete history will be taken from 
the patients and the ear canal to be assessed by otoscopy.  The aural toilet of all patients will be 
done via suctioning of the ear canal. In Group A patient’s ear canal will be filled with 1% 
clotrimazole ointment by using an Intravenous catheter and syringe In Group B pyodine solution-
soaked gel foam will be placed in the external auditory canal. Followup of patients was done on 
the 7th and 14th post-treatment days otoscopy will be performed and post-treatment symptom 
resolution and ear canal condition will be assessed.  
 
DATA ANALYSIS PROCEDURE: 
The collected data will be analyzed by SPSS version 23. Descriptive studies will be used to 
analyze qualitative and quantitative variables.Qualitative variables will be represented by 

frequency and percentage.For quantitative variables Mean+ Standard Deviation will be 
calculated. Comparison between outcomes of two groups will be done by using two sample t test 
or paired t test.A p value <0.05 will be taken as significant 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

REFERENCES 
 
1. Kiakojuri K., Taghizadeh Armaki M., Rajabnia R., et al. Outer ear infections in Iran: a 
review. Open Access Macedonian Journal of Medical Sciences. 2019;7(7):1233–1240. 
doi: 10.3889/oamjms.2019.176.     
 
 
2. Jimenez-Garcia L., Celis-Aguilar E., Díaz-Pavón G., et al. Efficacy of topical 
clotrimazole vs. topical tolnaftate in the treatment of otomycosis. A randomized 
controlled clinical trial. Brazilian Journal of Otorhinolaryngology. 2019;18 
 
3. Jwery AK. Various topical antifungal agents in otomycosis, which is the best? J Pak Med 
Assoc. 2021 Dec;71(Suppl 8)(12):S32-S34. PMID: 35130214. 
 
4. Haq M, Deshmukh P. Review of Recurrent Otomycosis and Clotrimazole in Its 
Treatment. Cureus. 2022 Oct 9;14(10):e30098. Doi: 10.7759/cureus.30098. PMID: 
36381881; PMCID: PMC9643015 
 
5. Chavan RP, Ingole SM, Kanchewad Resident GS. Single Topical Application of 1% 
Clotrimazole Cream in Otomycosis. Indian J Otolaryngol Head Neck Surg. 2022 Dec 
8:1-8. doi: 10.1007/s12070-022-03206-x. Epub ahead of print. PMID: 36532230; 
PMCID: PMC9734867. 
 
 
6. Swain SK, Behera IC, Sahu MC, Das A. Povidone iodine soaked gelfoam for the 
treatment of recalcitrant otomycosis–Our experiences at a tertiary care teaching hospital 
of eastern India. Journal de mycologie medicale. 2018 Mar 1;28(1):122-7.     
 
7. Mofatteh MR, Yazdi ZN, Yousefi M, Namaei MH. Comparison of the recovery rate of 
otomycosis using betadine and clotrimazole topical treatment. Brazilian journal of 
otorhinolaryngology. 2018 Jul;84:404-9.