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Comparing two anti-fungal drug combination in the treatment of fungal infection.

Completed
Conditions
Diseases of the skin and subcutaneous tissue,
Registration Number
CTRI/2023/11/059827
Lead Sponsor
meenakshi medical college hospital and research institute
Brief Summary

·       Dermatophytic infections are the most common fungal infections affecting 20%–25% population globally.

·       It is caused by all species of dermatophytes like Microsporum,Trichophyton and Epidermophyton which colonises the keratinized tissue using keratin as nutrition.

·       Terbinafine is considered to be a first-line drug for the treatment of tinea corporis and tinea cruris due to its favorable mycological and pharmacokinetic profile.

·       It acts by inhibiting the enzyme squalene epoxidase, thereby inhibiting ergosterol synthesis. Recently, there has been an increase in the incidence of terbinafine resistance with increasing numbers of clinical failures and relapses

·       One of the principal mechanisms of antifungal resistance is decrease in effective drug concentration.

·        It has been observed recently that there has been widespread resistance to various antifungal agents used in conventional dose with an increase in relapse rates prompting a need to find an effective first-line antifungal drug and appropriate dosage and duration schedule and topical agent to achieve maximum results with fewer relapses.

·       Hence, the present study was conducted to compare the efficacy of oral terbinafine with ketoconazole versus itraconazole with ketoconazole in the treatment of tinea corporis and tinea cruris.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
100
Inclusion Criteria
    1. Patient with diagnosis of tinea corporis and tinea cruris confirmed by KOH microscopy.
  • 2)Patients for whom documented consent has been obtained regarding their voluntary participation in this clinical study.
  • 3)Patients aged 18 years or older at the time that they provide consent.
  • 4)Patient agrees not to take other treatments than those provided in the study.
Exclusion Criteria
  • 1)Patient below 18 years of age.
  • 2)Pregnant and lactating mothers.
  • 3)Patient who are immunocompromised due to disease or drugs.
  • 4)Patient with pre existing renal,hepatic diseases and cardiac failure.
  • 5)Patient with history of hypersensitivity to itraconazole, terbinafine and ketoconazole.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Patients overall satisfaction frombaseline and at 4 weeks
the conditionbaseline and at 4 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Meenakshi Medical College Hospital and research institute

🇮🇳

Kancheepuram, TAMIL NADU, India

Meenakshi Medical College Hospital and research institute
🇮🇳Kancheepuram, TAMIL NADU, India
Deepak Raj
Principal investigator
8973378778
Deepakhbk44444@gmail.com

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