Mild to moderate onychomycosis
Conditions
Interventions
Product Name: Ciclopirox (CP) Nail Product
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Ciclopirox
CAS Number: 29342-05-0
Concentration unit: % (W/W) percent weight/weight
Concentratio
Sponsors
Stiefel Laboratories (Maidenhead) Limited trading as Stiefel International Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with mild to moderate distal subungual onychomycosis (defined as less than 74% nail involvement) with at least one big toenail affected (target nail). 2. Positive potassium hydroxide (KOH)/calcofluor preparation and positive dermatophyte culture. 3. Subjects aged between 18-70 years, inclusive. 4. Subjects who are willing and able to provide written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Sexually active women of childbearing potential participating in the study not using a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. 2. Female subjects who are pregnant or breast feeding. 3. Subjects with white superficial or proximal subungual onychomycosis involving the nail matrix. 4. Subjects who have previously received anti-fungal therapy either systemically or topically within 6 months prior to screening. 5. Subjects with a history of immuno-suppression or peripheral vascular disease or peripheral neuropathy. 6. Subjects with a history of skin disease or allergy likely to interfere with the study or known hypersensitivity to the investigational medicinal products or their ingredients. 7. Subjects who have participated in a clinical trial for the treatment of onychomycosis within six months or used an investigational drug within 30 days of recruitment into the study or at any time during their participation. 8. Subjects with a biochemistry laboratory result outside of the normal reference range, which are considered clinically significant by the Investigator. 9. Subjects who are either immediate family members, or colleagues, of study personnel. 10. Subjects who are unable to apply the product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of Ciclopirox (CP) nail product compared to Mycoster and vehicle (placebo), applied daily over 12 weeks, in subjects with mild to moderate distal onychomycosis. Primary endpoint - tolerability as measured by the investigator tolerance assessments (inflammation and scaling) and the investigator overall rating of tolerance.;Secondary Objective: Subject tolerance assessments (burning and pruritus), adverse events (AEs), routine biochemistry and the percentage of target nail affected at Visit 5 compared to baseline.;Primary end point(s): Equivalent tolerance parameters to Mycoster and placebo. | — |
Countries
Iceland
Outcome results
None listed