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
- Conditions
- Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
- Registration Number
- CTRI/2022/05/042655
- Lead Sponsor
- Dr Deval Mistry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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.
2. Patients with diagnosis of Glabrous tinea on KOH mount requiring systemic antifungal therapy.
3. 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).
4. 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.
5. Patients who the study staff deems reliable and mentally competent to carry out the study.
Patients meeting any of the following criteria must not be enrolled in the study:
1. Pregnant or nursing females.
2. Patients with known hypersensitivity to the study drugs.
3. Patients with liver dysfunction.
4. 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 subjectââ?¬•s safety or interfere with the study assessments.
6. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectââ?¬•s ability to safely complete the study.
7. History of drug or alcohol dependency or abuse within approximately the last 2 years.
8. 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.
9. Patients with malignancy.
10. 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).Timepoint: 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 <br/ ><br>o Percentage of patients achieving clinical cure. (Clinical cure is defined as absence of clinical signs and symptoms at the end of therapy) <br/ ><br>o Percentage of patients achieving mycological cure. (Mycological cure is defined as negative microscopy under potassium hydroxide (KOH) examination at the end of therapy). <br/ ><br>o Improvement in quality of life by Dermatology Life Quotient Index (DLQI) questionnaireTimepoint: 6 weeks