A clinical study to see the effect and safety of super bioavailable Itraconazole 50 mg vs 65 mg in a disease condition called Glabrous tinea

Phase 4

Completed

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2022/05/042655
• Lead Sponsor: Dr Deval Mistry

Brief Summary

Open label, prospective, randomized, comparative, double arm study.Eligible patients will be screened and upon confirmation on KOH mount will beenrolled in the study. Efficacy and safety assessments will be done at week 3and week 6. Follow up of all completely cured patients will be done at week 10for recurrence if any as an exploratory endpoint. Quality of Life will beassessed pre and post treatment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-10
• Study Start: 2022-05-23
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients eligible for enrolment in the study must meet all of the following criteria: 1.
• Both male and female patients aged ≥ 18 years and ≤ 60 years.
• Patients with diagnosis of Glabrous tinea on KOH mount requiring systemic antifungal therapy.
• Females of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
• Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
• Patients who the study staff deems reliable and mentally competent to carry out the study.

Exclusion Criteria

• Patients meeting any of the following criteria must not be enrolled in the study: 1.
• Pregnant or nursing females.
• Patients with known hypersensitivity to the study drugs.
• Patients with liver dysfunction.
• Patients with a history of seizures 5.
• Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
• Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
• History of drug or alcohol dependency or abuse within approximately the last 2 years.
• Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
• Patients with malignancy.
• Any patient whom the investigator judged to be inappropriate for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is to evaluate the proportion of patients achieving complete cure at Week 6 following doses of super bioavailable itraconazole 65 mg BD compared to 50 mg BD (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy).	6 weeks

Secondary Outcome Measures

Name	Time	Method
o The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal and derangement in Liver function test (LFTs) will be summarized by treatment groups	o Percentage of patients achieving clinical cure. (Clinical cure is defined as absence of clinical signs and symptoms at the end of therapy)

Trial Locations

Locations (1)

B J Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

B J Medical College and Civil Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Bela Shah

Principal investigator

9898059289

belashah769@gmail.com