Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Itraconazole: Group B- oral Itraconazole 100 mg BD after meal for 4 weeks
Intervention2: Itraconazole: Group C- oral Itraconazole 200 mg BD after meal for 2 weeks
Control Intervention1:
Sponsors
Pt BD Sharma PGIMS Rohtak
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient 18-65 years of age of either gender 2. Patient who has recurrence of lesions of tinea corporis and tinea cruris in less than 6 weeks after clinical cure 3. Patient willing to provide written informed consent. 4. Patients willing to come for regular follow up.
Exclusion criteria
Exclusion criteria: 1. Patient who has recurrence of lesions of tinea corporis and tinea cruris in less than 6 weeks after completion of treatment with Itraconazole and having been cured clinically. 2. Patient suffering from tinea infections other than tinea corporis and tinea cruris. 3. Patients with a history of intolerance or hypersensitivity to the study drugs. 4. Patients who have serious concomitant illness which can prevent the completion of study. 5. Patients with contact dermatitis, atopic dermatitis, psoriasis or any other skin disease. 6. All pregnant and breastfeeding females. 7. Patients with hepatic, renal or cardiac disease. 8. Patients on drugs that are contraindicated for use with itraconazole, which include pimozide, dofetilide, quinidine, oral midazolam, triazolam, nisoldipine, felodipine, dihydroergotamine, ergotamine, ergometrine, methylergometrine, cisapride, lovastatin, simvastatin, levacetylmethadol, and methadone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in physician assessment four-point scale 2. Change from baseline in KOH mount 3. Change from baseline in Dermatology Life Quality Index(DLQI) 4. Frequency and nature of Adverse drug reactionsTimepoint: Physician Assessment four-point scale, KOH mount and Dermatology Life Quality Index to be evaluated at 0,2,4,6 weeks. Any Adverse Drug reaction if occurs at any point in the study, has to be reported promptly and ADR monitoring to be done throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in Clinical response scale 2. Global clinical assessment at the end of treatment 3. Number of patients requiring escape treatment 4. Adherence to treatmentTimepoint: Clinical response scale is to be evaluated at 0,2,4,6 weeks. Global clinical assessment is to be done at the end of treatment. Number of patients requiring escape treatment is to be mentioned at the end of the study. Adherence in Chronic Diseases Scale (ACDS)to be evaluated at 2, 4 weeks. | — |
Countries
India
Contacts
Public ContactDr Bharat Pant
Pt B. D. Sharma PGIMS Rohtak
Outcome results
None listed