Study of 3 different dosages i.e Itraconazole 100mg vs 200mg vs 400mg or 5mg/kg whichever is lower in treatment of dermatophytosis (Ringworm)
Not yet recruiting
- Conditions
- Other specified local infections of the skin and subcutaneous tissue,
- Registration Number
- CTRI/2020/08/027063
- Lead Sponsor
- SOA university
- Brief Summary
This study is a triple arm, open label, randomized control trial comparing the safety and efficacy of Itraconazole 100 mg vs 200 mg vs 400mg or 5 mg/kg whichever is lower in the treatment of dermatophytosis. This study will be conducted at IMS and SUM hospital, Bhubaneswar, India. The primary outcome measures will be KOH status, culture status, clinical clearance at 4th week and 6th week. The secondary outcome will be safety of the drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
1.All naive cases of dermatophytosis 2.Potassium hydroxide (KOH) positive cases 3.Treated cases but off treatment from topical/systemic antifungal for the last four weeks.
Exclusion Criteria
- 1.Pregnant or lactating females.
- 2.History of diabetes.
- 3.Immunosuppressed patients.
- 4.Patient on drugs that interfere with itraconazole metabolism 5.History of hepatic and renal impairment.
- 6.Cases of congestive heart failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method KOH status Outcome will be assessed after completion of study in june 2021. Culture status Outcome will be assessed after completion of study in june 2021. Clinical clearance Outcome will be assessed after completion of study in june 2021.
- Secondary Outcome Measures
Name Time Method Safety profile In terms of side effects of the drug at 4th week and 6th week
Trial Locations
- Locations (1)
IMS and SUM hospital
🇮🇳Khordha, ORISSA, India
IMS and SUM hospital🇮🇳Khordha, ORISSA, IndiaDr Abhishek LachurePrincipal investigator9309986054lachureabhishek@gmail.com