












































Journal of Enam Medical College
Vol 11 No 1 January 2021

39

Original Article

Comparative Study of Topical Terbinafine 1% Cream versus 
Butenafine 1% Cream in the Treatment of Tinea Cruris

Meher Afsun1, Iftekhar Ahmed 2
Received: 30 December 2019    Accepted: 30 December 2020

doi: https://doi.org/10.3329/jemc.v11i1.63172

Abstract

Background: Tinea cruris constitutes a major health problem worldwide. Although not life-
threatening, it can cause significant discomfort in daily activities. So, search for better therapeutic 
options in terms of clinical efficacy and safety profile is ongoing. Objective: To compare the 
efficacy and safety of topical terbinafine 1% and butenafine 1% cream in the treatment of tinea 
cruris. Materials and Methods: This Comparative interventional study was carried out in the 
Dermatology & Venereology department of Bangabandhu Sheikh Mujib Medical University 
between October 2014 and March 2015. A total of 50 patients of tinea cruris who met the inclusion 
criteria and provided consent were enrolled in the study. They were then divided into two groups 
as Group A (terbinafine group) and Group B (butenafine group) in a 1:1 ratio following a simple 
randomization method. Patients were advised to apply the medication once daily for 2 weeks 
and evaluated on the basis of clinical assessment score at the end of 1 and 2 weeks. Results: The 
baseline socio-demographic characteristics of the two groups were not statistically significantly 
different. Higher clinical cure was observed in butenafine recipients as compared with terbinafine 
recipients on the basis of mean clinical assessment score at the end of 7 days (5.72±0.7 vs 4.12±0.7) 
and 14 days (3.04±0.5 vs 1.44±0.9). The difference was statistically significant at both the time 
points. Both the drugs were well-tolerated except one patient of terbinafine group complained of 
transient burning.  Conclusion:  Treatment with butenafine 1% cream can be considered superior 
to terbinafine 1% cream in case of tinea cruris.

Key words: Tinea cruris; Dermatophytosis; Terbinafine cream; Butenafine cream

              J Enam Med Col 2021; 11(1): 39−46  

1. Assistant Professor, Department of Dermatology and Venereology, Enam Medical College & Hospital, Savar, Dhaka
2. Assistant Professor, Department of Dermatology and Venereology, Sir Salimullah Medical College & Mitford 

Hospital, Dhaka
Correspondence Meher Afsun,Email: drmafsun@gmail.com

Introduction

Tinea cruris, a pruritic superficial fungal infection 
of the groin and adjacent skin, is the second most 
common clinical presentation for dermatophytosis. It 
is an important clinical problem that may, at times, 
be a diagnosticas well as therapeutic challenge.1 
Tinea cruris has a worldwide distribution but is found 
more commonly in hot, humid climates and affects 
individual of all age and sex.2,3 It is a contagious 

infection transmitted by fomites or by autoinoculation 
from a reservoir on the hands or feet (tinea manuum, 
tinea pedis and tinea unguium). The most common 
etiologic agents for tinea cruris include Trichophyton 
rubrum and Epidermophyton floccosum; less 
commonly Trichophyton mentagrophytes and 
Trichophyton verrucosum are involved.1

Topical preparations with good local bioavailability 



January 2021J Enam Med Col Vol 11 No 1

40

are the commonly used and preferred first line agents 
in the treatment of localized dermatophytosis. Their 
improved efficacy aims to shorten the treatment period 
with fewer side effects. Ease of application, enhanced 
patient compliance, and minimal recurrences also add 
to the therapeutic response.4 Quest for more potent 
and more compliant medication is going on. Finding a 
medication with more potency and capability to treat 
this disorder at less inconvenience will empower the 
dermatologist and the general physicians to fight the 
disorder with better efficacy.

Clinical cure of an uncomplicated tinea cruris infection 
usually can be achieved using topical antifungal 
agents.5 Many topical antifungals of different groups 
are available for the treatment of dermatophytosis 
such as azole derivatives, allylamines, benzylamines, 
morpholine, etc.6 Terbinafine hydrochloride is one 
of the fungicidal allylamine group of drugs with 
broad spectrum of antifungal activity. It interferes 
with fungal sterol biosynthesis at an early stage.7 

Butenafine hydrochloride is a novel, benzylamine 
derivative with a chemical structure and mode of 
action is similar to allylamine antifungals.8 It likes 
the allylamines, butenafine also inhibits squalene 
epoxidation, blocking the biosynthesis of ergosterol, 
an essential lipid component of fungal cell membrane. 
The antifungal activity of both allylamine and 
benzylamine results from ergosterol deficiency 
and intracellular accumulation of squalene, which 
interferes with fungal cell membrane function and 
synthesis.7,8

The dermatophytes responsible for tinea cruris have 
been shown to be susceptible to both terbinafine and 
butenafine.9,10 However, comparative study between 
topical terbinafine 1% and butenafine 1% cream in 
the treatment of tinea cruris is lacking. Under these 
circumstances, the current study was undertaken to 
compare the efficacy and safety of topical terbinafine 
1% and butenafine 1% cream in the treatment of tinea 
cruris.

Materials and Methods

This prospective, randomized, open-labeled 

comparative interventional study was conducted 
on 50 patients over the age of 14 years who visited 
Dermatology and Venereology outpatient department 
of Bangabandhu Sheikh Mujib Medical University 
(BSMMU) duringthe period of October 2014 to 
March 2015, a duration of 6 months. The inclusion 
criteria comprised of untreated patients of tinea 
cruris whose diagnosis was confirmed by potassium 
hydroxide (KOH) examination for fungal elements 
and who had at least three signs and symptoms of 
tinea cruris namely pruritus (symptom); polycyclic 
lesions, erythema, scaling, macerations, papules and 
vesiculation (signs). Patients were excluded from the 
study, if they had received topical or oral antifungals 
either one to four weeks prior to the initiation of 
the study respectively, history of hypersensitivity to 
allylamine or benzylamine anti-fungal agents, any 
known severe systemic disease, immunocompromised 
status, pregnant or lactating women.

All potential patients were screened following the 
inclusion and exclusion criteria, then the first 50 
patients who met those criteria and provided consent 
were enrolled in the study. Informed written consent 
was at first obtained from all the patients, then a 
structured questionnaire was administered to gather 
valuable information about socio-demographic 
characteristics and disease-related informations.

The patients were then randomized into two groups 
as group A (n=25) and group B (n=25) in a 1:1 
ratio following a simple randomization method by 
allocatinga code for each patient.

At the initial visit, all the study patients underwent 
detailed physical and cutaneous examination.  All 
clinical details were recorded on a predesigned 
proforma. The symptoms and signs like erythema, 
scaling and pruritus were designated on a scale of 
0 to 3 as follows: 0=none, 1=mild, 2=moderate and 
3=severe. The individual symptom scores were added 
and a total score (clinical assessment score) was 
recorded.

Group A patients were treated with terbinafine 
1% cream and group B patients were treated with 



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butenafine 1% cream. Patients were advised to apply 
the medication after bath to the affected sites and also 
to the surrounding areas, once daily for 2 weeks.

The patients were then clinically evaluated at the end 
of one and two weeks (i.e., at the end of treatment 
period). At each visit, thorough clinical examination 
was carried out and clinical assessment score was 
calculated to determine clinical efficacy. Adverse 
effects, if any, were also recorded at each visit. 
Clinical efficacy was defined in this study as reduction 
in the severity of symptoms and signs of tinea cruris 
(pruritus, erythema, scaling, etc.) as evident by 
decreased clinical assessment score from baseline 
during follow-up visit. 

All data were collected at first using a structured 
paper-based questionnaire containing all the variables 
of interest. Data were then initially extracted in 
Microsoft Excel, coded, cleaned and then entered into 
Statistical Package for Social Sciences version 16.0 
for Windows (SPSS Inc., Chicago, Illinois, USA) for 
further statistical analyses. The mean values were 
calculated for continuous variables. The quantitative 
observations were indicated by frequencies and 
percentages. Chi-Square test with Yates correction 
was used to analyze the categorical variables, shown 
with cross tabulation. Student t-test/unpaired t-test 
was used for continuous variables. p values <0.05 
were considered as statistically significant.

Results

There was a total of 50 patients, 25 patients in the 
terbinafine group (Group A) and 25 patients in the 
butenafine group (Group B).  In group A (terbinafine 
group), majority of the patients were in the age group of 
21−30 years. In group B (butenafine group), majority 
of the patients were in the age group of >30 years. The 
mean age with SD in group A (terbinafine group) and 
group B (butenafine group) were 31.88±11.08 years 
and 30.40±9.51 years respectively. The difference 
between the age of two group was not statistically 
significant (p=0.614).

Proportion of male was higher than female in group 

A (terbinafine group), which was 76.0% and 24.0% 
cases respectively. Same is also true for group B 
(butenafine group), where proportion of male versus 
female was 84.0% vs16.0% cases respectively. 
The difference between these two groups was not 
statistically significant (p=0.479).

Distribution of study participants on the basis of 
marital status showed that in group B (butenafine 
group), married persons were more than unmarried 
persons which was 16 (64.0%) cases and 9 (36.0%) 
cases respectively. Similar distribution was observed 
in group A (terbinafine group), where proportion of 
married and unmarried persons was 56.0% cases and 
44.0% cases respectively. The difference between 
these two groups was not statistically significant 
(p=0.563).

Majority of the patients of group A (terbinafine group) 
were graduate and above level which was 9 (36.0%) 
cases followed by SSC, HSC, primary school and 
illiterate which were 6 (24.0%) cases, 6 (24.0%) 
cases, 3 (12.0%) cases and 1 (4.0%) case respectively. 
Somewhat similar pattern was observed among the 
patients of group B (butenafine group) where majority 
were graduate and above level which is 11 (44.0%) 
cases followed by primary school, SSC, HSC, and 
illiterate which were 6 (24.0%) cases, 4 (16.0%) 
cases, 3 (12.0%) cases and 1 (4.0%) case respectively. 
The difference between these two groups was not 
statistically significant (p=0.628).

Service was the main occupation of the patients of 
group A (terbinafine group). We found 15 (60.0%) 
cases in this category followed by student, housewife, 
business and laborers which were 5 (20.0%) cases, 
2 (8.0%) cases, 2 (8.0%) cases and 1 (4.0%) case 
respectively. In contrast, among the patients of 
group B (butenafine group) majority (9, 36.0%) were 
students followed by service, housewife, laborers 
and business which were 8 (32.0%) cases, 3 (12.0%) 
cases, 3 (12.0%) cases and 2 (8.0%) cases respectively. 
The difference between these two groups was not 
statistically significant (p=0.345) (Table I).



January 2021J Enam Med Col Vol 11 No 1

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Table I: Characteristics of the study participants

Characteristics Group A (n=25)Number (%)
Group B (n=25)

Number (%) p values

Age in years
<21 03 (12.0) 06 (24.0)

0.614ns
21−30 13 (52.0) 07 (28.0)
>30 09 (36.0) 12 (48.0)
Mean ± SD 31.88 ±11.08 30.40 ±9.51
Sex
Male 19 (76.0) 21 (84.0)

0.479ns
Female 06 (24.0) 04 (16.0)
Marital Status
Married 14 (56.0) 16 (64.0)

0.563ns
Single 11 (44.0) 09 (36.0)
Educational Level
Illiterate 01 (4.0) 01 (4.0)

0.628 ns
Primary School 03 (12.0) 06 (24.0)
SSC 06 (24.0) 04 (16.0)
HSC 06 (24.0) 03 (12.0)
Graduate & above 09 (36.0) 11 (44.0)
Occupation
Service 15 (60.0) 08 (32.0)

0.345ns
House wife 02 (8.0) 03 (12.0)
Student 05 (20.0) 09 (36.0)
Business 02 (8.0) 02 (8.0)
Laborers 01 (4.0) 03 (12.0)
ns = Not significant

Baseline clinical presentation of the study 
participants

Most of the study participants (88%) had presented 
with multiple lesions in both group A (terbinafine 
group) and group B (butenafine group). The difference 
between these two groups was not statistically 
significant (p=1.000). In group A (terbinafine group), 
erythema was present in 25 (100.0%) cases, scaling 
was present in 25 (100.0%) cases, central clearing 
was present in 22 (88.0%) cases, papule was present 

in 23 (92.0%) cases, vesicles was present in 9 (36.0%) 
cases, maceration was present in 5 (20.0%) cases and 
pruritus was present in 25 (100.0%) cases. In group 
B (butenafine group), erythema was present in 24 
(96.0%) cases, scaling was present in 23 (92.0%) 
cases, central clearing was present in 19 (76.0%) cases, 
papule was present in 21 (84.0%) cases, vesicles was 
present in 10 (40.0%) cases, maceration was present 
in 6 (24.0%) cases and pruritus was present in 24 
(96.0%) cases, The difference was not statistically 
significant (p>0.05) between two groups (Table II).



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Table II: Presentation of Tinea cruris among the study participants

Characteristics Group A (n=25)
Number (%)

Group B (n=25)
Number (%)

p values

Number of lesions
Multiple 22 (88.0) 22 (88.0)

1.000nsSingle 03 (12.0) 03 (12.0)
Clinical findings
Erythema 25 (100.0) 24 (96.0) 0.312ns

Scaling 25 (100.0) 23 (92.0) 0.148ns

Central Clearing 22 (88.0) 19 (76.0) 0.269ns

Papule 23 (92.0) 21 (84.0) 0.333ns

Vesicles 09 (36.0) 10 (40.0) 0.770ns

Maceration 05 (20.0) 06 (24.0) 0.732ns

Pruritus 25 (100.0) 24 (96.0) 0.500ns
ns= Not significant

Comparison of clinical assessment score between 
the groups before and after treatment

The mean and standard deviation (SD) of clinical 
assessment score in group A (terbinafine group) 
and group B (butenafine group) were 8.92 ± 0.6 and 
8.84±0.8 respectively before initiation of treatment. The 
difference between the mean score of two group was 
not significant (p=0.690). After one week of treatment 
the mean clinical assessment score with SD of group 

A (terbinafine group) and group B (butenafine group) 
participants were 5.72±0.7 and 4.12±0.7 respectively. 
The difference between the mean score of the two 
groups was significant (p=0.001). The mean clinical 
assessment score with SD in group A (terbinafine 
group) and group B (butenafine group) were 3.04±0.5 
and 1.44±0.9 respectively after 2 weeks of treatment. 
The difference between the mean score of the two 
groups was significant (p=0.001)  (Table III  and Fig 1).

Table III: Comparative Clinical assessment score between the groups before and after treatment

Follow up & observation           Group A
        (Mean ± SD)

                Group B
               (Mean ± SD)

     P value

Base line 8.92±0.6 8.84±0.8 0.690ns

After 1st week 5.72±0.7 4.12±0.7 0.001s

After 2nd week 3.04±0.5 1.44±0.9 0.001s

ns=Not significant; s= Significant

Fig  1. Line graph showing the improvements of the study patients according to clinical assessment scoring



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Comparison of adverse effects between the groups 
after treatment

Transient burning sensation at the application site 
was found in one of 25 (4.0%) cases of Group A 
(terbinafine group); but it resolved spontaneously 
and did not require discontinuation of therapy. In 
contrast, no side effects were reported by Group B 
(butenafine group) participants. The difference was 
not statistically significant (p>0.05).

Discussion 

Newer classes of antifungals like the allylamines 
and benzylamines were developed to combat the 
increasing incidence of resistant fungal infections as 
well as to produce quicker response with lesser side 
effects. Terbinafine and butenafine are the antifungals 
that represent the groups respectively and both were 
tested individually for their efficacy. However, there is 
still paucity of published evidence where their efficacy 
has been compared together. Under this circumstance, 
our current study which to the best of our knowledge 
was the first study in Bangladesh that compared the 
efficacy and safety of topical terbinafine 1% and 
butenafine 1% cream in the treatment of tinea cruris. 

In the present study, it was observed that in group A 
(terbinafine group), majority of the patients (52.0%) 
were in their 3rd decade of life followed by more than 
30 years (36.0%) and under 21 years (12.0%). In 
Group B (butenafine group), majority of the patients 
were in the age group of more than 30 years (48.0%) 
followed by 3rd decade and under 21 years which were 
28.0% cases and 24.0% cases respectively. The mean 
age with SD in group A (terbinafine group) and group 
B (butenafine group) were 31.88±11.08 years and 
30.40±9.51 years respectively, which were similar in 
two groups. The mean difference between the age of 

two groups was not statistically significant (p>0.05), 
which indicates that tinea cruris is predominant in 
3rd decade and above. Similarly, Choudhary et al11 
showed in their study that all the patients had similar 
demographic features with age ranged in between 
16 and 35 years in both the groups. Das et al12 also 
found most of the patients’ age belonged to 30−45 
years accounting for 67.0% of the study group. The 
youngest patient was 18 years and the oldest patient 
was 61 years, which are consistent with the findings 
of our current study. On the other hand, Jerajani et al13 
and Rotta et al14 observed higher mean age in their 
respective studies, which were 36.49±14.70 years 
and 38.4±13.4 years respectively. The higher mean 
age might be due to geographical variations, racial, 
ethnic differences, genetic causes, different lifestyle 
and increased life expectancy.

Tinea cruris is a dermatophyte infection of the 
groin and is more common in men than in women 
probably because males perspire more than females, 
greater areas of occlusive skin where the scrotum is 
in contact with the thigh and clothing difference.15 
Similarly, in this current study it was observed that 
in Group A (terbinafine group) male was predominant 
than female which was 76.0% cases and 24.0% cases 
respectively. In Group B (butenafine group) males 
were predominant compared with females (84.0% 
cases and 16.0% cases respectively). The difference 
between these two groups was not statistically 
significant (p>0.05). Male to female ratio was 3.2:1 
and 5.3:1 in Group A (terbinafine group) and Group 
B (butenafine group) respectively and 4:1 in the 
whole study patients. As regards to the incidence of 
tinea cruris, a number of other studies found male 
predominance (11−14), which closely resembles with 
the findings of the present study. 

Table IV: Comparison of adverse effects among the treatment groups

           Side effect Group A (n=25)
Number (%)

Group B (n=25)
Number (%)

      P value

Burning
 Yes 01 (4.0) 0 (0.0)

0.500ns
 No 24 (96.0) 25 (100.0)
ns= not significant



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It was observed in this study that, the mean clinical 
assessment scoring with SD in Group A (terbinafine 
group) and Group B (butenafine group) were 8.92 
± 0.6 and 8.84±0.8 respectively at baseline before 
initiation of treatment. The difference between the 
mean score of two groups is not significant (p=0.690). 
The mean clinical assessment scoring with SD in 
Group A (terbinafine group) and Group B (butenafine 
group) were 5.72±0.7 and 4.12±0.7 respectively after 
1 week of treatment. The difference between the mean 
score of the two groups was significant (p=0.001). The 
mean clinical assessment scoring with SD in Group A 
(terbinafine group) and Group B (butenafine group) 
were 3.04±0.5 and 1.44±0.9 respectively after 2 weeks 
of treatment. The difference between the mean score 
of the two groups was significant (p=0.001). Ramam 
et al9 observed in the butenafine group, the clinical 
score declined from a mean of 7.36  at baseline to 
1.5±1.43 at week 2, 1.04±1.55 at week 4, 1.45±2.3 
at week 6 and 1.5±2.3 at week 8. The reduction in 
the sign and symptom score from baseline at 4 weeks 
post-treatment follow-up in the butenafine treated 
group was 81.5%.9 Similar findings were also reported 
by Singal et al16 where they showed that mean clinical 
assessment score declined from 6.65±1.29 at baseline 
to 1.00±0.62 at 2nd week, 0.56±0.51 at 4th week and 
0.65±0.49 at the end of 8th week in the group treated 
with butenafine.

One single study by Das et al12 that compared these 
two drugs butenafine and terbinafine in the treatment 
of tinea cruris showed that at the end of 42 days, 
the overall cure rates were 79.49% in the Regimen 
II (butenafine) group and 62.16% in the Regimen I 
(terbinafine) group. The effective treatment rates after 
2 weeks of post-treatment follow-up was 92.31% in 
Regimen II (butenafine) and 81.08% in Regimen I 
(terbinafine) study group which were all statistically 
significant (p<0.05). The study concluded that 
treatment with butenafine 1% cream was considered 
superior to treatment with terbinafine 1% cream in 
case of tinea cruris.12

In this study, it was observed that burning was found 
in 1(4.0%) case in Group A (terbinafine group) and not 
found in Group B (butenafine group). The difference 
was not statistically significant (p>0.05) between 

two groups. Similar findings were also reported by a 
study of Jerajani et al13, where only one patient using 
terbinafine 1% cream had complained of burning 
sensation on application. This could be attributed to 
the pharmacological property of any topical antifungal 
drug or hypersensitivity to the study drug, that could 
not be assessed as the patient was lost to follow-up.17

In conclusion, results of our present study revealed 
that there were significant difference between the 
mean clinical assessment score of the two groups at the 
end of 2 weeks treatment period. Butenafine produced 
the quickest result and clinical efficacy was much 
higher with butenafine cream than that of terbinafine 
cream and this difference was statistically significant. 
Therefore, treatment with butenafine 1% cream was 
reported superior to treatment with terbinafine 1% 
cream in case of tinea cruris.

Strength and Limitations of the study

Although this study was important due to its unique 
nature of being the first study done in low-resource 
setting exploring the efficacy of butenafine 1% cream 
and terbinafine 1% cream in treatment of tinea cruris, 
its findings should be interpreted in light of some 
limitations. The first limitation was that the study 
population which was selected from one selected 
hospital of Dhaka city, so that the results of the 
study might not reflect the exact picture of the whole 
country. Moreover, the present study was conducted 
over a very short period of time on a small sample 
size which was also a limitation of the present study. 
Therefore, in future further study may be under taken 
with large sample size and robust methodology.

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