A clinical study to assess the effectiveness and side effects of Naftifine Cream 2% in patients with fungal infection of foot.
- Conditions
- Health Condition 1: B353- Tinea pedis
- Registration Number
- CTRI/2022/06/043131
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 198
1. Male and Female Patients aged between 18 to 65 years (both inclusive).
2. Patients with clinical diagnosis of tinea pedis with lesions predominantly localized to the interdigital spaces on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
3. Patients with the sum of the clinical signs and symptoms scores of the target lesion is at least 5, including a minimum score of at least 2 for erythema and scaling and 1 for pruritus (on a scale of 0-3, where 2 indicates moderate severity).
4. Patients with mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic 10% Potassium Hydroxide (KOH) wet mount examination.
5. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
7. Patients willing to comply with the protocol requirements.
1. Patients with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot.
2. Patients with known hypersensitivity to allylamine and/or azole antifungal agents.
3. Patients with clinical laboratory evaluations (hematology, biochemistry and routine urine analysis) are not within the reference range for the testing laboratory or the results are deemed clinically significant by the investigator.
4. Patients with known case of type 1 diabetes and type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
5. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patientâ??s participation in the study.
6. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
7. Patients with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
8. Patients using antipruritics, including antihistamines, within 72 hours prior to randomization.
9. Patients using topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to randomization.
10. Patients using systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to randomization.
11. Patients using oral Terbinafine or Itraconazole within 2 months prior to randomization.
12. Patients using immunosuppressive medication or radiation therapy within 3 months prior to randomization.
13. Patients with history of dermatophyte infections unresponsive to systemic or topical antifungal drugs.
14. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
15. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
16. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
17. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
18. Suspected inability or unwillingness to comply with the study procedures.
19. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving clinical cure at Day 42 (±3 days) / Week 6.Timepoint: At Day 42
- Secondary Outcome Measures
Name Time Method Adverse events / serious adverse events reported during the study.Timepoint: Throughout the study;Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).Timepoint: At Visit 1/Screening Visit, Day 14 and Day 84;Proportion of patients achieving clinical cure at Day 84 (±3 days) / Week 12.Timepoint: At Day 84;Proportion of patients achieving complete clearance at Day 42 (±3 days) / Week 6 and at Day 84 (±3 days) / Week 12.Timepoint: At Day 42 & Day 84;Proportion of patients achieving mycological cure at Day 42 (±3 days) / Week 6 and at Day 84 (±3 days) / Week 12.Timepoint: At Day 42 & Day 84