Health Condition 1: null- Superficial Tinea Infections
Conditions
Interventions
Intervention1: Biovites® CalmagenTM Dermaceutical cream & lotion,: Twice daily, Topical application for 4 weeks
Control Intervention1: A matching placebo cream & lotion,: Twice daily Topical applica
once daily for 3 months (during observation phase)
Sponsors
Biovite Australia Pty Ltd
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for entry in this study, patient must: 1. Be a male or female >= 18 years of age 2. Be diagnosed by the Principal Investigator or designee as suffering from Tinea of combined severity (itching, erythema and scaling) score of 8 or more as in appendix 3 or severe grade of onychomycosis as in appendix 4 of protocol 3. Subjects with positive KOH and positive fungal culture test along with identification of the dermatophyte and presence of live spores. 4. Understand and conform to the procedures involved in and agree to participate in the study by giving informed, written consent. 5. Be able to give consent for taking photographs of the affected region before, during and after the study period.
Exclusion criteria
Exclusion criteria: To be eligible for entry in this study, patient must not: 1. Have used any oral or topical Tinea treatments, within one week prior to the screening assessment. 2. Have ingested any drug in the week prior to the start of treatment or during the treatment period, which, in the opinion of the Principal Investigator, could compromise the study (Note: Oral, injectable or implant contraceptive for female volunteers is acceptable). 3. Have history of allergy or intolerance to any drug, which in the opinion of the principal investigator poses a risk to the patient 4. Be pregnant or breast-feeding females. 5. Have received an investigational drug or participated in a clinical trial within the last 30 days 6. Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Principal Investigator, may be jeopardized by participation in this study or by the complications of this therapy 7. Hypersensitivity to Biovite® dermaceutical formulation (cream & lotion) 8. Patient with a positive test for hepatitis B, C, and who is positive or reactive for antibodies to HIV 1 and 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mycological cure assessed by negative KOH preparation, fungal culture, and reduction in live spore counts at the end of studyTimepoint: End of study (4 weeks for Tinea & 12 weeks for Onychomycosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in lesions assessed by photographic record at baseline and at end of studyTimepoint: End of study (4 weeks for Tinea and 12 weeks for Onychomycosis);Reduction in the extent and the severity of onychomycosis since baseline and at the end of the study.Timepoint: End of study (12 weeks for Onychomycosis);Reduction in the size and the severity of tinea lesions since baseline and at the end of studyTimepoint: End of study (4 weeks for Tinea) | — |
Countries
India
Contacts
Public ContactMr Rakesh Naranbhai Dadhania
Manipal Acunova
Outcome results
None listed