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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.

â??COMPARISON OF ORAL ITRACONAZOLE PLUS TOPICAL LULICONAZOLE VERSUS ORAL ITRACONAZOLE PLUS TOPICAL AMOROLFINE VERSUS ORAL ITRACONAZOLE PLUS EMOLLIENT IN THE MANAGEMENT OF EXTENSIVE TINEAâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029231
Enrollment
129
Registered
2020-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B354- Tinea corporis Health Condition 2: B356- Tinea cruris

Interventions

Intervention1: ORAL ITRACONAZOLE FOR TREATMENT OF TINEA: ITRACONAZOLE 100 MG BD TILL CURE OR 6 WEEKS WHICHEVER IS EARLIER IN ALL THREE STUDY GROUPS. Intervention2: ORAL ITRACONAZOLE AND TOPICAL LULICO

Sponsors

RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
TO COMPARE THE CLINICAL CURE AMONG THE 3 GROUPS.Timepoint: 2, 4, 6, 8, 12, 16 WEEKS.—

Secondary

MeasureTime frame
TO COMPARE MYCOLOGICAL CURE AMONG THE 3 GROUPS. TO ASSESS THE THERAPY-RELATED ADVERSE EFFECTS IN EACH GROUP. TO FOLLOW UP EACH GROUP FOR POST TREATMENT RELAPSE. Timepoint: 2, 4, 6, 8, 12, 16 WEEKS.—

Countries

India

Contacts

Public ContactDR KARTHICK K

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

saurabhdoc@yahoo.co.in9968024250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026