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Efficacy and Safety of Terbinafine and Itraconazole

NCT05881980 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-05-31

No results posted yet for this study

Summary

There is a rise in the prevalence in recent years especially in tropical countries along with an increase in the number of treatment failures with chronic and recurrent dermatophytosis. There is a huge gap between the treatment required in the present scenario and the treatment guidelines given in the standard books. The aim of the study is to determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of dermatophytosis. The study design will be a randomized parallel-group trial. Patients will be randomly divided into five parallel arms in which two of the standard drugs in recommended doses will be compared with their double doses and with a combination of both drugs. The patients will be reevaluated at 2, 4, 6, and 8 weeks of treatment (the end of therapy), using the physician Global Assessment (PGA) Scale. The cure will be considered a complete clinical resolution of the lesions. The patient's response to the treatment will be recorded. Safety and patient compliance will be recorded at each follow-up visit. Findings of observation will be recorded on a pre-prescribed and pre-tested data collection form. After collection, all data will be checked and compiled. Data will be processed and analyzed using computer software with statistical packages for social science SPSS-26. An analysis plan will be developed keeping in view the objectives of the study. The results of the continuous measurement will be presented on mean ± SD (mean-max) and results on categorical measurements will be presented in numbers (%). A p\<0.05 will be considered statistically significant. Results will be disseminated to all Dermatology departments in Bangladesh.

Conditions

  • Tinea Corporis
  • Tinea Cruris
  • Tinea Faciei
  • Dermatophytoses

Interventions

DRUG

Terbinafine Tablets

Terbinafine 250 mg/day

DRUG

Itraconazole

Itraconazole 200 mg/day

Sponsors & Collaborators

  • Dhaka Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-10-31
Completion
2023-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881980 on ClinicalTrials.gov