A single centre, double blind, placebo controlled, randomized, confirmatory efficacy study of bioviteÂ®s calmagenTM dermaceutical cream & lotion for the topical treatment of tinea

Biovite Australia Pty Ltd0 个研究点目标入组 28 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 BioviteÂ® 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.

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