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Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
ISSN 2278 – 5221 www.ijpmbs.com
Vol. 2, No. 4, October 2013
2013 IJPMBS. All Rights Reserved
A COMPARATIVE STUDY OF EFFICACY OF
TERBINAFINE AND FLUCONAZOLE IN PATIENTS
OF TINEA CORPORIS
Kumar Amit1*, Budania Navin2, Sharma Priyamvada3 and Singh Monika4
*Corresponding Author: Kumar Amit,  : [email protected]
Objectives: This study aimed to compare the efficacy of terbinafine and fluconazole in thetreatment of Tinea corporis.Material and methods: Total 116 tinea corporis patients who werenot responding to topical antifungal therapy of 2 weeks were selected and they were randomlydivided into two groups. Group-I received oral terbinafine (250 mg) daily for 4 weeks. Group-IIreceived oral fluconazole (150 mg) once weekly for 4 weeks. Evaluation is done by assessmentof target symptoms, i.e., scaling, erythema, and pruritus (as clinical score 0 to 3) and by Clinicalresponse rates at the end of treatment. Results: There was a significant decrease in the clinicalscore beginning from baseline to 4th week in both the groups (P < 0.05). If we compare theclinical score of both the groups after 4th week, there is slight more reduction of clinical score ingroup-I than of group-II (P > 0.05). The clinical response rate of group-I at 4th week was 92.86%,whereas Clinical response rate of group-II was 82.00% (P > 0.05). Conclusion: Both fluconazoleand terbinafine are quite effective in the treatment of tinea corporis patients in terms of clinicalcure. Terbinafine shows slightly better results than fluconazole (P > 0.05).
Key words: Fluconazole, Terbinafine, Tinea corporis, Clinical response rate
Patients typically present with an annular patch or plaque with an advancing, raised, scaling Tinea corporis is a superficial dermatophyte border and central clearing. The tinea corporis infection characterized by either inflammatory or infection begins as flat, scaly, and often pruritic noninflammatory lesions on the glabrous skin (i.e., macules that subsequently develop a raised skin regions except the scalp, groin, palms, and border and begin to spread radially. As the ring soles). It is most commonly caused by expands, the central portion of the lesion often Trichophyton species, that digest keratin in the clears. This pattern leads to the formation of cells of the stratum corneum.
Department of Pharmacology, Major SD Singh Medical College, Farrukhabad, India.
Department of Pharmacology, S.H.K.M. Govt. Medical College, Mewat, Haryana, India.
Department of Pharmacology, S.N. Medical College, Agra, India.
Major SD Singh Medical College, Farrukhabad, India.
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Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
irregular circles that gives tinea corporis its Agra. Patients were randomly selected from the common name, ringworm.
tinea cases of extensive tinea corporis attending Most patients with tinea corporis are diagnosed skin OPD. Approval of Institutional Ethical clinically. To avoid a misdiagnosis, identification Committee was taken to conduct the above study.
of dermatophyte infections requires both a fungal culture on Sabouraud's agar media, and a Tinea corporis patients of both sexes and age mycological examination, consisting of a 10% to between 20-45 years, patients who were not 15% KOH preparation, from skin scrapings.
responding to topical antifungal therapy of 2 Although topical antifungals may be sufficient weeks, patient must be culture positive, patients for treatment of tinea corporis, but systemic from Agra or around Agra, patients do not having medications are used for patients with severe any other systemic disease, patients ready for infection, for infections that do not respond to therapy after knowing adverse effects.
topical therapy, when the infected areas are large, macerated with a secondary infection, or in Evidence of hepatic or renal disease, pregnant females, nursing mother, age <20 years and >45 Common systemic antifungal agents used are years, hypersensitivity or intolerance to treatment, oral griseofulvin, terbinafine, fluconazole and patients who takes cisapride.
itraconazole. Azole and Allylamine agents appear Workup Before Therapy
to have greater efficacy and fewer side effectsthan oral Griseofulvin. Terbinafine and After selecting the patient, a detailed clinical record itraconazole are equally effective in treating tinea was prepared including age, sex, address, corporis (Farag et al., 1994 and Parent et al., occupation, family history, duration of the disease, 1994). An alternative is fluconazole which is given size and extent of lesions, history of previous orally once a week for up to four consecutive treatments. Then cases were examined in detail weeks (Suchil et al., 1992 and Montero and for local and systemic examination. After that all Perera, 1992). Fluconazole, a synthetic triazole patients were subjected to necessary derivative, is an azole antifungal agent.Terbinafine investigations which include-Hb, TLC, DLC, is an allylamine. It is a synthetic antifungal agent.
ESR, blood sugar, weight of patient, SGPT/ Our study is a comparative study between SGOT, serum creatinine, urine analysis. The fluconazole and terbinafine in terms of efficacy.
investigations were repeated after 2 weeks andafter end of treatment.
MATERIAL AND METHODS
This prospective, parallel, open-label, All the patients of tinea corporis attending to the randomized, comparative clinical trial was out patients department were selected for the conducted in the department of pharmacology in study, on the basis of inclusion and exclusion collaboration with department of skin and venereal criteria. Total 116 patients were selected and they diseases from February 2010 to January 2011 at were randomly divided into two groups. Two S N. Medical College and Associated Hospital, This article can be downloaded from http://www.ijpmbs.com/currentissue.php
Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
groups which were compared and evaluated are Follow Up and Evaluation
Patients were followed at 1st week, 2nd week and4th week (after the end of treatment). Evaluation GROUP I (Daily Oral terbinafine): In this group
is done by clinical assessment in terms of clinical patients were given oral terbinafine (250 mg) daily score and clinical response rates. The clinical at morning time after breakfast for 4 weeks.
signs and symptoms assessed were scaling, GROUP II (Weekly Oral Fluconazole): In this
erythema, and pruritus. These three were group patients were given oral fluconazole (150 regarded as target symptoms. The signs and mg) once weekly at morning time after breakfast symptoms were rated as clinical score 0 to 3: 0, for 4 weeks.
absent; 1, mild; 2, moderate; or 3, severe, for theabove three target symptoms. At the global clinical Out of 116 patients 24 patients missed during evaluations, we rated the clinical findings as: A.
the treatment period. Therefore only 92 patients Healed (absence of signs and symptoms), B.
were included in the study for detail analysis (42 Markedly improved (>50% clinical improvement), patients in the terbinafine group and 50 patients C. Considerable residual lesions (< 50% clinical in the fluconazole group) (Figure 1).
improvement), D. No change, E. Worse.
Figure 1: Showing Flow Diagram of Material and Method
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Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
Clinical response rates : A clinical response to
mean age of the sample was 30.36 ± 6.64 years treatment was defined as a rating of healed or (Group I- 30.40 ± 6.69 years and Group II- 30.32 markedly improved.
± 6.67 years). The maximum number of patients, i.e., 51 (55.43%) were in age group 21-30 years.
Lower extremities were the most common site The data was analyzed using online statistical of involvement, i.e., 51 patients (55.43%). The calculators. Wilcoxon Signed-Ranks Test was most common causative organism reported was used to compare the paired data of same group T. rubrum 51 cases (55.43%) (Tables 1 and 2).
and Mann-Whitney Test was used to comparethe data of both groups. P < 0.05 was considered The mean clinical score at baseline was 6.42 as statistically significant.
± 1.52 (Group I- 6.43 ± 1.50 and Group II- 6.42 ±1.55). There was significant decrease in the clinical score beginning from baseline to 4th week In present study, total of 92 patients of tinea in both the groups (P < 0.05). If we compare the corporis of age group 20-45 years were analyzed.
clinical score of both the groups after 4 week there Among them 42 patients were given daily therapy is slight more reduction of clinical score in group- of terbinafine (group I) and 50 patients were given I than of group-II (P > 0.05).
weekly therapy of fluconazole (group II). A detailed The clinical response rate of group-I at 4th week analysis revealed that the disease was more was 92.86%, whereas of group-II was 82.00%.
common in males, the male to female ratio being There is slight more increase in clinical response 1.36:1, i.e., 57.61% were males and 42.39% were rate in group-I than of group-II (P > 0.05) females (Group I-1.47:1, Group II-1.27:1). The Table 1: Clinical Scores in Group-I and Group-II
Group-I (n =42)
Group-II (n =50)
At Baseline
At Baseline
Table 2: Clinical Scores in Group-I Vs. Group-II
At Baseline
Group -II
Group -II
Group –I
Group -II
Group –I
Group -II
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Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
Figure 2: Clinical Response Rates at the End of Treatment in Group I Vs. Group II
were males and 35.00% were females (Acharyaet al., 1995).
Tinea corporis occurs worldwide and is relativelyfrequent, but its incidence is higher in tropics and The mean age of patients was 30.36 ± 6.64 subtropics. Males are infected more than females.
years. The youngest person was of 21 years and Infection can occur from direct or indirect contact the eldest was of 45 years. The maximum with skin and scalp lesions of infected persons number of patients, i.e., 51 (55.43%) were in age group 21-30 years and the least number of Topical therapies for treatment of tinea patients, i.e., 8 (8.70%) belongs to age group corporis include terbinafine, butenafine, between 41-45 years. In a study by Decroix et al.
econazole, miconazole, ketoconazole, (1997), the mean age of tinea corporis/ tinea clotrimazole, and ciclopirox. Topical formulations cruris patients was 39.7 years (Decroix et al., may eradicate smaller areas of infection, but oral therapy may be required where larger areas are In the present study the most common involved or where infection is chronic or recurrent causative organism isolated after culture report (Gupta et al., 2003).Oral itraconazole, terbinafine, was T. rubrum, 51 cases (55.43%) followed by and fluconazole have been used successfully in T. tonsurans, 20 cases (21.74%), M. canis, 11 the treatment of tinea corporis/ tinea cruris.
cases (11.96%) and T. Mentagrophytes, 10 cases Out of 92 patients, 53 were male and 39 were (10.87%). In a research study conducted by female. A predominance of male patients was Venkatesan et al. shows T. rubrum (69.6%) was seen. The overall male to female ratio in the study the major causative species isolated, followed by was 1.36:1, i.e., 57.61% were males and 42.39% T. mentagrophytes (28.2%) and M. gypseum were females. In a study by Acharya et al. (1995), (2.2%) from tinea corporis patients (Venkatesan the male to female ratio was 1.86, i.e., 65.00% et al., 2007).
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Int. J. Pharm. Med. & Bio. Sc. 2013
Kumar Amit et al., 2013
In the present study the mean clinical score at likewise without symptoms. Fluconazole once a baseline was 6.42 ± 1.52 (Group I- 6.43 ± 1.50 week for 6 weeks was both clinically and and Group II- 6.42 ± 1.55). The maximum number mycologically effective in the treatment of tinea of patients, i.e. ,21 (22.82%) were in the score of corporis and tinea cruris (Faergemann et 6 (Group I-10 patients, i.e., 23.81% and Group II- 11 patients, i.e., 22.00%). The minimum number In a study by Voravutinon V. the 250 mg of oral of patients, i.e., 9 (9.78%) were in the score of 9 terbinafine once daily or 500 mg of griseofulvin (Group I- 4 patients, i.e., 9.52% and Group II-5 once daily for 2 weeks. The results after 6 weeks patients, i.e., 10.00%). There was significant follow-up, showed the mycological cure in decrease in the clinical score beginning from terbinafine and griseofulvin group was 87.1 and baseline to 4th week in both the groups (P < 0.05).
54.8%, respectively. The clinical response of the After 4 week of therapy the maximum number of terbinafine group was also significantly higher patients, i.e., 65 (70.65%) were in the score of than in the griseofulvin group (Voravutinon, 1993).
zero (Group I- 32 patients, i.e., 76.19% and GroupII-33 patients, i.e., 66%). If we compare the clinical score of both the Groups after 4 week there is Tinea corporis is a common problem slight more reduction of clinical score in Group-I encountered in dermatology practice. It is more than of Group-II. The difference between these common in males than females. It mainly involves two clinical scores was not statistically significant Lower extremities and trunk. T. rubrum is the (P > 0.05).
most common causative organism. Both The clinical response rate of Group-I at 4th fluconazole and terbinafine are quite effective in week was 92.86%, whereas, of Group-II was the treatment of tinea corporis patients in terms 82.00%. There is slight more increase in clinical of clinical cure. Terbinafine shows slightly better response rate in Group-I than of modality-II, but results than fluconazole but the difference the difference between these two clinical between these two is not statistically significant response rates was not statistically significant (P (P > 0.05). The lower cost and once weekly > 0.05). In an open, non-comparative trial by schedule of fluconazole may favor patient Suchil et al. employing once weekly dosing of compliance with lesser number of drop-outs.
fluconazole 150 mg for 1 to 4 weeks for tineacorporis and tinea cruris, clinical cure rate was 92% with long-term clinical cure rate of 88% 1. Acharya K M, Mukhopadhyay A, Thakur R (Suchil et al.,1992).
K, Mehta T, Bhuptani N and Patel R (1995), Faergemann et al. compared fluconazole 150 "Itraconazole versus griseofulvin in the mg once a week with griseofulvin 500 mg once a treatment of tinea corporis and tinea cruris", day for 4-6 weeks in the treatment of tinea Indian J Dermatol Venereol Leprol, Vol. 61, corporis and tinea cruris. In the fluconazole group, 74% (80 out of 114) were clinically cured; in the 2. Decroix J, Fritsch P, Picoto A, Thürlimann griseofulvin group, 62% (72 out of 116) were W and Degreef H (1997), "Short-term This article can be downloaded from http://www.ijpmbs.com/currentissue.php
Int. J. Pharm. Med. & Bio. Sc. 2013
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itraconazole versus terbinafine in the 7. Parent D, Decroix J and Heenen M (1994), treatment of superficial dermatomycosis of "Clinical experience with short schedules of the glabrous skin (tinea corporis or cruris)", itraconazole in the treatment of tinea Eur J Dermatol, Vol. 7, pp. 353-7.
corporis and/or tinea cruris", Dermatology, 3. Faergemann J, Mork N J, Haglund A and Vol. 189, pp. 378-81.
Odegard T (1997), "A multi-centre (double- 8. Suchil P, Gei F M, Robles M, Perera-Ramirez blind) comparative study to assess the A, Welsh O and Male O (1992), "Once- safety and efficacy of fluconazole and weekly oral doses of fluconazole 150 mg in griseofulvin in the treatment of tinea corporis the treatment of tinea corporis/cruris and and tinea cruris", Br J Dermatol, Vol. 136, cutaneous candidiasis", Clin Exp Dermatol, pp. 575–7.
Vol. 17, pp. 397- 401.
4. Farag A, Taha M and Halim S (1994), "One- 9. Venkatesan G, Ranjit Singh A J A , Murugesan week therapy with oral terbinafine in cases A G, Janaki C and Gokul Shankar S (2007), of tinea cruris/corporis", Br J Dermatol, Vol.
"Trichophyton rubrum – the predominant 131, pp. 684-6.
etiological agent in human dermatophytoses 5. Gupta AK, Chaudhry M and Elewski B in Chennai", India Afr J Microbiol Res, pp.
(2003), "Tinea corporis, tinea cruris, tinea nigra, and piedra", Dermatol Clin, Vol. 21,pp. 395–400.
10. Voravutinon V (1993), "Oral treatment of tinea corporis and tinea cruris with 6. Montero-Gei F and Perera A (1992), terbinafine and griseofulvin: a randomized "Therapy with fluconazole for tinea corporis, double blind comparative study", J Med tinea cruris, and tinea pedis", Clin Infect Dis, Assoc Thai, Vol. 76, pp. 388-93.
Vol. 14, pp. 77-81.
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