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.