Onychomycosis
Conditions
Interventions
Product Name: Mycosinate
Product Code: A3IS
Pharmaceutical Form: Gel
INN or Proposed INN: Glucose
CAS Number: 77938-63-7
Current Sponsor code: CTP001B
Other descriptive name: GLUCOSE
Concentration uni
Sponsors
Nektr Technologies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Confirmed presence of hyphae through microscopy of nail sample taken from patient. (Further details of nail sampling given in section 2.7.5) • In good overall health (Subject to Health Assessment conducted by the responsible Physician). • Male and Female aged between 18-65 inclusive. • The fungal infection is seen across 20-75% of the nail with no involvement of the lunula. (Details of nail sizing protocol given in section 2.8.1) • Subject is willing and available to return for study follow ups. • Subject is willing to discontinue use of cosmetic nail products for the duration of the study. • Subjects must agree to refrain from using other nail fungus treatments for the duration of the study • Physical examination without significant deviations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diabetics. • Severe cases of onychomycosis (e.g. complete coverage of nail). • Chronic conditions such as immune deficiency, chronic vascular disease or psoriasis. • Currently involved in another clinical trial. • Patients who are pregnant or breastfeeding. • Severe secondary dermal infections • Patients suffering from proximal subungual onychomycosis • Any medical condition which may place the patient at risk of infection or delayed wound healing • Patients using immunosuppressant drugs • Other conditions known to cause an abnormal nail appearance • Known allergy to any of the ingredients in the study treatments • Patient has been using any antifungal therapy for the removal of the infection, either systemic or topical, in the past 6 months. • Patients who have damaged or broken periungual skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. % Reduction in the Size of Infection Photos taken during the trial will be analyzed by the statistician who will measure both the entire size of the nail and the size of the infected portion of the nail. Using this data, the statistician will be able to calculate the % reduction in the size of the infection as the trial progresses. 2. Viability of the Infection at Time ‘T’ (Mycological Cure Rate) Confirmation testing will be carried out in a 3rd party contract laboratory and will be cultured to determine the viability of the infection at the various time points in the study. ;Secondary Objective: 1. Relapse Rates The viability testing carried out from the month 6 follow up visit will form the relapse rate results. If the infection is viable at 9 month and was not viable at month 6 then the patient has relapsed. 2. Adverse Reactions Any adverse reactions will be recorded and serious adverse reactions will be reported directly to the HPRA via the sponsor’s pharmacovigilance provider, Diamond Pharma Services. ;Primary end point(s): 1) Viability of the infection 2) % Reduction in the Size of Infection (Visual improvement) ;Timepoint(s) of evaluation of this end point: Both primary endpoints assessed at T=0 weeks, 3 weeks, 6 weeks, 12 weeks, 6 months and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Relapse rates 2) Adverse events ;Timepoint(s) of evaluation of this end point: 1) Relapse rates - measured at 6 month and 9 month visits 2) Adverse events - recorded throughout duration of study | — |
Countries
Ireland
Contacts
Public ContactRegulatory Affairs
Diamond BioPharm Limited
Outcome results
None listed