Status:
NOT_YET_RECRUITING
Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
Lead Sponsor:
University of Bologna
Collaborating Sponsors:
Dionisio Franco Barattini, MD, MBA, MSc
Conditions:
Onychomycosis of Toenails
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the ...
Detailed Description
In Italy the prevalence of onychomycosis in subjects aged \>65 years was as high as 35%. This observational, retrospective study has the objective to evaluate the safety and effectiveness of two treat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Patients clinically and microscopically KOH diagnosed with distal and lateral subungual onychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following OSI6.
- Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes
Exclusion
- Other types of onychomycoses.
- Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.
- Pregnant woman, lactating woman.
Key Trial Info
Start Date :
May 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06971341
Start Date
May 30 2025
End Date
December 30 2025
Last Update
May 20 2025
Active Locations (1)
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1
UOC di Dermatologia - IRCCS Policlinico di Sant'Orsola - Università di Bologna
Bologna, BO, Italy, 40138