A CLINICAL TRIAL TO COMPARE THE EFFECTS OF ORAL ANTIFUNGAL DRUG - ITRACONAZOLE IN COMBINATION WITH THREE DIFFERENT TOPICAL DRUGS LIKE LULICONAZOLE, AMOROLFINE AND MOISTURISER IN PATIENTS WITH RINGWORM.
- Conditions
- Health Condition 1: B354- Tinea corporisHealth Condition 2: B356- Tinea cruris
- Registration Number
- CTRI/2020/11/029231
- Lead Sponsor
- RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
PATIENTS WITH DERMATOPHYTOSIS,FULFILLING THE FOLLOWING CRITERIA WILL BE INCLUDED IN THE STUDY, AFTER INFORMED WRITTEN CONSENT.
1. AGE > 18YRS
2. NEW, RECURRENT OR CHRONIC DERMATOPHYTOSIS (NOT ON TREATMENT FOR PAST 1 MONTH WITH ORAL ITRACONAZOLE OR FOR PAST 2WEEKS WITH OTHER ORAL/TOPICAL ANTIFUNGALS).
3. CLINICAL SUSPICION OF TINEA CORPORIS, CRURIS OR FACIEI.
PATIENT HAVING ANY OF THE FOLLOWING CRITERIA WILL BE EXCLUDED FROM THE STUDY.
1.PRESENCE OF ANY OTHER TYPES OF TINEA (E.G. ONYCHOMYCOSIS, TINEA CAPITIS, PEDIS, MANNUM).
2.UNCONTROLLED DIABETES( TWO TEST READINGS OF HBA1C > 7.0)
3.PREGNANCY AND LACTATION
4.PATIENTS WITH ANY PRIMARY OR SECONDARY IMMUNODEFICIENCY
5.PATIENTS WITH EXTENSIVE AND ACTIVE ATOPIC DERMATITIS.
6.HISTORY OF DRUG REACTION OR ALLERGY TO ANY OF THE 3 STUDY MEDICATIONS
7.PRESENCE OF CARDIAC DISEASE(CHF), LIVER DISEASE OR SEVERE RENAL DISEASE REQUIRING ITRACONAZOLE DOSE ADJUSTMENT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TO COMPARE THE CLINICAL CURE AMONG THE 3 GROUPS.Timepoint: 2, 4, 6, 8, 12, 16 WEEKS.
- Secondary Outcome Measures
Name Time Method TO COMPARE MYCOLOGICAL CURE AMONG THE 3 GROUPS. <br/ ><br>TO ASSESS THE THERAPY-RELATED ADVERSE EFFECTS IN EACH GROUP. <br/ ><br>TO FOLLOW UP EACH GROUP FOR POST TREATMENT RELAPSE. <br/ ><br>Timepoint: 2, 4, 6, 8, 12, 16 WEEKS.