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. 2020 Jan 16;2020(1):CD012093. doi: 10.1002/14651858.CD012093.pub2

NCT03814343.

Trial name or title Comparison of effectiveness of topical amphotericin B in 30% dimethylsulphoxide (DMSO) and 30% DMSO in treating non‐dermatophytes onychomycosis: Randomised double‐blind controlled trial pilot study
Methods RCT (parallel)
Study design: Double blind
Sample size calculation: No
Diagnosis mycology: Culture
Big toenail specified: Unknown
Statistical comparisons for outcomes: Unknown
Duration of follow‐up: 36 weeks
Time points of measurements: At week 36
Participants Total n: 20
Age: 18 years and older.
Sex: Men and women (ratio unknown)
Inclusion criteria: Adults 18 years of age and older diagnosed with non‐dermatophyte onychomycosis and have not been treated with any oral/IV/topical antifungal therapy within 36 weeks before enrolled
Exclusion criteria: People with dermatophyte onychomycosis, immunocompromisation, or concomitant nail diseases
Disease duration: Unknown
Comparable at baseline: Unknown
Causative species: Non‐dermatophytes
Number of people lost to follow‐up: Unknown
Interventions Treatment duration: 12 weeks
Drug in study arm 1: Amphotericin B in 30% DMSO, n = 10
Drug in study arm 2: Placebo (30% DMSO), n = 10
Outcomes Mycological cure at 36 weeks
Clinical cure (complete clinical improvement or < 10% nail involvement) at 36 weeks
Adverse events over 12 weeks
Median time to mycological and clinical cure
Starting date 15 January 2019
Contact information Name: Dr. Charussri Leeyaphan, M.D.
Email: charussrilee@gmail.com
Department of Dermatology, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Location Department of Dermatology, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Notes Study record updated 29 January 2019, status is recruiting

BMI: body mass index; DSO: distal subungual onychomycosis; GMS: KOH: potassium hydroxide; PAS: periodic acid‐Schiff; PCR: polymerase chain reaction; PSO: proximal subungual onychomycosis; RCT: randomised controlled trial.