Tinea Corporis
Tinea Corporis
Tinea Corporis
2018;16(3)112-118
Original Article
Abstract:
Introduction: Tinea corporis also known as ‘ringworm’ is dermatophytosis of the trunk. It usually presents as an annular
plaque with a slightly raised and often scaly, advancing border. Topical azoles in combination with steroids are commonly
prescribed. But it is unclear whether they are superior to topical azoles alone or not.
Objective: To compare the clinical efficacy of 1% topical clotrimazole cream vs combination of 1% isoconazolenitrate
(ISN)with 0.1%diflucortolone valerate (DFV) cream in patients of tinea corporis.
Methods : A randomized controlled trial was performedon 380 patients of outdoor dermatology unit of Pakistan Institute of
Medical Sciences, Islamabad. They were randomly allocated to two groups by lottery method named Group A who were
given topical 1% clotrimazole cream (an antifungal) and Group B who were given topical 1% isoconazole nitrate (an
antifungal) and 0.1% diflucortolone valerate cream (a corticosteroid). Both groups were asked to apply respective cream
twice daily for two weeks.
Results: Among 190 patients of study group A, where 123 (64.70%) patients showed complete clinical cure, 67 (35.3%) still
had existent any of the three signs of tinea corporis, hence had negative clinical efficacy. Comparatively in group B, 126
(66.3%) patients showed complete clinical cureand 64 (34.70%) showed persistence of either of the clinical signs of tinea
corporis after treatment. Even though the clinical efficacy showed slightly better results with ISN and DFV group, the
difference was also not statistically significant. (d.f. 1, χ statistic 0.10, p- value 0.74)
Conclusion: There is no significant difference in clinical efficacy of clotrimazole vs isoconazole nitrate and diflucortolone
valerate cream and both are effective treatments for tinea corporis. Azole monotherapy being cheaper should be preferred
over combination treatment.
Key Words: Clotrimazole, isoconazole nitrate, difucortolone valerate, tinea corporis
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hosts or very extensive and severe infections might require still considered controversial and subject to debate, and
additional oral treatment. Different groups of antifungals are some clinicians even consider this a form of ‘mistreatment’,
available which include azoles, allylamines, benzylamines, and that it might lead to tinea incognito. The overall
hydroxypyridones and thiocarbamates, but it is uncertain duration of the included studies was too short for any
which are the most effective.7 The azoles are the most assessment and side effects were not reported. So, they
widely used antifungal drugs.There are two groups of azoles could be justified for inflammatory dermatophytosis for
in current clinical use: the imidazoles, and triazoles. short duration but evidence for this is weak.7
Isoconazole and clotrimazole belong to the imidazole
group.8Clotrimazole has been widely used topically for the At present, there is no consensus in literature on the use of
treatment of tinea corporis and there is no report of combination of topical antifungals with corticosteroids in
resistance to this drug in dermatophytosis till the treatment of tinea corporis. So the purpose of this study
now.9Isoconazole nitrate (ISN)is a broad-spectrum was to compare the efficacy of plain imidazole
antimicrobial agent with a highly effective antimycotic and (clotramizole) alone versus combination of imidazole and
gram-positive antibacterial activity, a rapid rate of steroid (ISN and DFV). Thus, it will help us in managing
absorption and low systemic exposure potential. such a common skin problem much more effectively. 14
Diflucortolone valerate (DFV) is a potent class III
corticosteroid8 Material And Methods
In this randomized controlled trial, patients with the clinical
Controversy exists on the use of antifungals with diagnosis of tinea corporis made by a dermatologist were
corticosteroids. One view is that it provides a synergistic selected and the presence of one of its clinical signs i.e.,
benefit in this condition because the steroid rapidly pruritus, scaling and erythema noted. Skin scrapings in
represses the inflammation responsible for the KOH, done only in selected cases, should show fungal
infection-related distress, while the antimycotic effectively hyphae. Sample size was calculated by WHO sample size
targets the pathogen.10,11 One of the example is the calculator and 380 patients were included in study.
combination of ISN with the DFV. Compared with ISN Consecutive non-probability sampling is done. Patients with
monotherapy, combination has a faster onset of antimycotic tinea corporis who have not received systemic or topical
action, faster relief of itch and other inflammatory antifungal agents and steroids during the last 1 month were
symptoms, improved overall therapeutic benefits and included in study. However, diabetics, immunodeficient,
improved mycological cure rate. The rapid alleviation of pregnant, lactating or those who are allergic to any of the
itch results in less damage to the skin barrier due to study drug were excluded from study. After approval from
scratching, and therefore, reduces the chance of secondary the ethical committee of hospital, informed consent was
bacterial infections. It also increases the local bioavailability obtained from the patients fulfilling the criteria and wishing
of ISN and prolongs its activity, leading to more rapid to participate in the study. Each subject was required to
normalization of skin conditions.8 However, this attend the clinic on two occasions during the study. In the
combination should be used judiciously in the treatment of first visit, the patient was screened for any excluding factor
cutaneous fungal infections and may not be appropriate for and demographic profile was recorded. Detailed medical
use in children.12Mark D. Andrews, in his article have not history was taken and clinical examination of the potential
recommended them because of a greater risk of adverse subjects was done to make the diagnosis of tinea corporis.
effects, primarily from the higher-potency steroid The patients were divided into two groups randomly using
component. Cure rates are lower and the cost is higher with random number table. One group was allocated topical
combination therapy than with antifungal creams 1%clotrimazole cream and second group was given
alone.12,13Similarly, Kelly in his review has not combination of 1% isoconazole and 0.1%diflucortolone
recommended them because these preparations are less valerate cream. The patients were instructed to apply the
effective.1,12 In a Cochrane review comprising of 129 cream thinly to the affected area twice daily for 2 weeks.
randomized controlled trials with 18,086 participants Patients enrolled for the study were not permitted to
evaluated a range of interventions; mostly azoles. concomitantly use any other antifungal other than the trial
Combinations of azoles with corticosteroids were evaluated drug or any other topical medication. No systemic
and found to be slightly more effective than azoles for antihistamine was
clinical cure, but there was no statistically significant
difference with regard to mycological cure. This treatment
approach is
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Int.j.pathol.2018;16(3)112-118
given. All the data was recorded on a specially designed Table I. Comparison of age, duration of illness & size of
performa by researcher separately for each case and duly lesion in study groups
verified by consultant and evidenced with detection of CHARACTE STUDY n ME STAN t- p-
RISTICS GROU (number AN DARD VALU VALU
fungal hyphae in KOH in difficult cases. The second visit PS of DEVIA E E
was on day 14 when the patient was called and compliance patients) TION
AGE IN Group 190 35.15 12.79 -0.15 0.87
determined from the trial diary. Clinical examination was YEARS A
repeated and physical scores assessed based on efficacy Group 190 35.35 12.55
parameters after evaluation of signs and symptoms. Clinical B
DURATION Group 174 18.76 7.56 -0.12 0.89
efficacy is the clearance of all the signs and symptoms of OF ILLNESS A
tinea corporis i.e., absence of pruritus, erythema and scaling IN DAYS Group 169 18.86 6.76
B
at the end of two weeks of treatment. SIZE OF Group 187 3.58 0.96 0.49 0.62
LESION IN A
CENTIMETE Group 188 3.53 1.02
Statistical analysis
RS B
Data was analyzed in SPSS version 16. The quantitative
variables like age and duration of illness were calculated by
The treated lesions were located in arms in 96 patients
taking means and standard deviation. The qualitative
(25.3%), legs in 111 patients (29.2%),while majority had
variables like gender and outcome variable like efficacy
lesions in trunk 173 (45.5%). The sites of lesion were
were calculated by taking frequency and percentages.
compared in both study groups as displayed in table II and
Confounding factors like age, gender, site, size and duration
no statistically significant difference was observed in both
of illness were controlled by stratification through Mantel
study groups (d.f. 2, χ statistic 0.94, p- value 0.62)
Haenszel Chi square test. Comparison of efficacy in two
groups was done by Chi-Square test. p value of <0.05 was
considered as significant.
Table II Comparison Of Sites Of Lesion In Study
Groups
Results SITE OF STUDY GROUPS
LESIONS GROUP A (n=190) GROUP B(n=190) TOTAL(N=380)
A total of 380 patients were included in the study, amongst Frequency Percentage Frequency Percentage Frequency Percentage
whom 190 were in group A receiving topical 1% ARMS 44 45.8% 52 54.2% 96 100.0%
LEGS 58 52.3% 53 47.7% 111 100.0%
clotrimazole cream and group B comprised of same number TRUNK 88 50.9% 85 49.1% 173 100.0%
of patients received 1% isoconazole and 0.1% Comparison of clinical efficacy in both study groups
diflucortolone valerate cream. The mean age of all 380 Amongst 190 patients of study group A, where 123
patients was 35.25 ±12.65 years (range 14-60 (64.70%) patients showed positive clinical efficacy and in
years).Regarding gender, 185 (48.7%) were males while group B, 126 (66.3%) patients showed positive clinical
195 (51.3%) were females. Out of 343 patients, mean efficacy. Even though the clinical efficacy showed slightly
duration of illness was found to be 18.81 days (SD± 7.17 better results with ISN and DFV group, the difference was
days; range 8 to 48 days). Out of 375 patients, the mean size also not statistically significant. (d.f. 1, χ statistic 0.10, p-
was recorded as 3.55 cm (SD±0.99 cm; range (2- 8cm). value 0.74) as shown in Table III and Graph 1.
Briefly discussing group characteristics, no statistically
significant difference was found in both study groups Table III: Comparison of Efficacy between both groups
regarding age (p=0.87), sex (p=0.60), duration of illness
(p=0.89),size of lesion (p=0.62) as shown in Table 1 and
site of lesion (p=0.62) shown in Table 2. Both male and Efficacy
Group Total
female are equal in group A whilein group B, 52.63% were Positive Negative
females and 47.37% were males, this difference was not
statistically significant (chi statistic 0.263, p-value 0.60). Group A (clotrimazole) 123 (64.7%) 67 (35.3%) 190
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Disappearance of individual features of tinea corporis Graph 4: Comparison of Scaling at Baseline With
Taking each of the features of tinea corporis individually, Scaling After Treatment In Both Study Groups
following statistics are shown. Prurius was observed to have Concominant existence of two or more features of tinea
disappeared in greater number of patients in group B corporis after treatment
i.e.,153 (80.5%) comparable to 125 (65.8%) patients of
study group A and this difference was highly statistically After two weeks of treatment, concomitant existence of any
significant in both study groups (d.f. 1, χ statistic 10.50, two or all the three features of tinea corporis was also
p- value 0.001)exhibited in Graph 2. looked for in both study groups and results are displayed in
Table III.
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Int.j.pathol.2018;16(3)112-118
Similarly, experts from India, considering the misuse of clotrimazole group, there is no significant difference in the
topical steroids already prevailing in their country, vetoed overall efficacy in both groups. Considering the high cost of
its use in tinea corporis.17Similar situation of topical steroids corticosteroid azole combinations, azole monotherapy
exist in our country. should be considered as first line treatment in patients on
In this study, isoconazole 1% is given in combination with tinea corporis.
0.1% diflucortolone valerate and its clinical efficacy is Conclusion
compared with 1% clotrimazole (another member of Topical Isoconazole nitrate with diflucortolone valerate and
imidazole group). The results however showed no topical clotrimazole are effective treatments for tinea
significant difference in clinical efficacy in both groups at corporis and there is no significant difference in their
the end of 2 weeks of treatment. clinical efficacy.
In the present study, though clinical efficacy was not
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