A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infectio

Phase 1

• Conditions: Onychomycosis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000294-78-IE
• Lead Sponsor: ektr Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified