Use of Itraconazole oral solution in Children with Fungal Infection

Completed

• Conditions: Dermatophytosis,

• Registration Number: CTRI/2019/05/019139
• Lead Sponsor: Dr Ramesh Bhat M

Brief Summary

Purpose of Trial

Presently dermatophytosis in India is resistant to treat and itraconazole is the widely used drug for the management considering the low response rate for previously used drugs like terbinafine, fluconazole and griseofulvin. Even though dermatophytosis in children is rare compared to adults, in the present epidemic it is seen in children also and the management of these recurrent and resistant dermatophytosis is a therapeutic challenge.

Even though itraconazole in capsule form is widely used, it is difficult to administer it in children considering the size of the capsule. In view of the recent availability of itraconazole oral solution, this can be effectively administered with ease in children. However, there are only a few studies in the literature for the treatment of dermatophytosis with oral Itraconazole solution, hence this study is conducted.

Itraconazole oral solution is efficacious and tolerable in Paediatric Dermatophytosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study Completion: 2020-10-30
• Last Update Posted: 2020-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients age group of 1to12 years with clinical diagnosis of cutaneous dermatophytosis in glabrous skin (Tinea faciei, Tinea corporis and Tinea Cruris).
• Both boys and girls will be included in the study.
• Patients /parents/guardians who are consenting to participate in the study.
• Patients with recurrent and extensive (10% body surface area) Tinea infection will be taken for the study.

Exclusion Criteria

• •Patients with other pre-existing skin disorders.
• •Patients/parents/guardians who are not willing to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of Oral Itraconasole solution in Paediatric age group	Two weeks and Four weeks

Secondary Outcome Measures

Name	Time	Method
Tolerability and side effects of oral itraconazole solution	2 weeks and 4 weeks

Trial Locations

Locations (1)

Father Muller Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Father Muller Medical College Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Ramesh Bhat M

Principal investigator

9845084224

rameshderma@gmail.com