Health Condition 1: B359- Dermatophytosis, unspecified
Conditions
Interventions
Intervention1: super bioavailable itraconazole: 130 mg once daily administered before breakfast for 4 weeks
Intervention2: Super bioavailable itraconazole: 100 mg once daily administered before breakf
Sponsors
Scarlet Clinic
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject able to understand and ready to provide written informed consent. 2.Males and females aged >=18 years, clinically diagnosis for tinea corporis or tinea cruris with clinical score >=5. 3.Consent of the participating subject to provide photography of the affected area before, during and after the study.
Exclusion criteria
Exclusion criteria: 1.Subjects not having tinea corporis or tinea cruris infection. 2.Subjects who received any oral or topical tinea treatments, within one week prior to screening or had ingested any drug in the week prior to start or during the treatment, which in the opinion of investigator could compromise the study. 3. Subjects with history of hypersensitivity to study drug, immunocompromised status or superadded bacterial infection. 4. Pregnant or lactating women. 5. Subjects with a serious illness (e.g. diabetes mellitus, collagen diseases, auto-immune diseases, hematological diseases and malignant tumors); and, those with liver dysfunction, kidney dysfunction or cardiac problems. 6.Subjects who received an investigational drug or have participated in a clinical trial within the previous 30 days. 7.Subject has history of drug dependence or excessive alcohol intake on a habitual basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum itraconazole AUC, trough itraconazole concentrations and sebum concentrations will be assessed . Clinical scoring and lesion photographs will be recorded followed by mycological assessment. Efficacy in terms of a number of patients achieving clinical cure ( No signs or symptoms of tinea infection erythema, scaling, pruritis, and papules, clinical score â?¤ 2) or mycological cure (Negative KOH microscopy) at the end of the study.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function tests (SGOT and SGPT) will be monitored at baseline and at the end of study.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactPayal Gupta
Delhi Institute Of Pharmaceutical Sciences And Research
Outcome results
None listed