Comparative serum and sebum concentrations and efficacy of orally administered conventional itraconazole 100 mg twice daily vs conventional itraconazole 200 mg once daily vs super bioavailable itraconazole 130 mg once daily vs super bioavailable itraconazole 100 mg once daily in subjects with Dermatophytosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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 ≤ 2) or mycological cure (Negative KOH microscopy) at the end of the study.
研究概览
简要总结
this study is a randomized, open label , parallel group, four arm, single center study comparing serum, sebum concentrations and efficacy of orally administered conventional itraconazole 100 mg twice daily vs conventional itraconazole 200 mg once daily vs super bioavailable itraconazole 130 mg once daily vs super bioavailable itraconazole 100 mg once daily in subjects with Dermatophytosis. patients ( 10 in each treatment group ) complying with the inclusion criteria will be enrolled in the study and baseline clinical score based on erythema, scaling, pruritis, and papules noted and graded on 4 point scale: Score 0=absent, 1=mild, 2=moderate, and 3=severe. Photographs of the lesions will be recorded and skin scraping for KOH smear will be collected for mycological assessment. Subjects were then randomly divided into four treatment groups: (A) Treatment 1: conventional ITZ 100 mg, twice daily; (B) Treatment 2: conventional ITZ 200 mg, once daily; (C) Treatment 3: super bioavailable ITZ 130 mg, once daily and (D) Treatment 4: super bioavailable ITZ 100 mg, once daily .At Day 0 blood samples at 0 min, 0.5, 1, 2, 4, 8, 12 and 24 h fromsubjects will be collected. Thereafter subjects were followed up at Day 3, Day 7, Day 14 and Day 28 (final visit) for collection of blood and sebum samples. At final visit (Day 28), the Clinical scoring and lesion photographs will be recorded followed by mycological assessment. For safety assessment liver function test will be performed at baseline and final visit. The data will be compared against baseline values of the individual subject and among treatments as per study primary and secondary end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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 ≥
- •3.Consent of the participating subject to provide photography of the affected area before, during and after the study.
排除标准
- •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.
- •Subjects with history of hypersensitivity to study drug, immunocompromised status or superadded bacterial infection.
- •Pregnant or lactating women.
- •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.
结局指标
主要结局
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 ≤ 2) or mycological cure (Negative KOH microscopy) at the end of the study.
时间窗: 4 weeks
次要结局
- Liver function tests (SGOT and SGPT) will be monitored at baseline and at the end of study.(28 days)