Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
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|ClinicalTrials.gov Identifier: NCT01851590|
Recruitment Status : Completed
First Posted : May 10, 2013
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Helsinki University Central Hospital
Information provided by (Responsible Party):
Janne J. Jokinen, Helsinki University Central Hospital
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment|
Device: Resin Lacquer
|Recruitment Details||In November 2013, on the basis of a newspaper advertisement, a total of 129 adult volunteers were assessed for eligibility at Vääksy Medical Center, Finland. Eligible subjects were required to provide toenail samples for screening. Inclusion criteria were a positive dermatophyte culture and a positive potassium hydroxide (KOH) stain.|
|Pre-assignment Details||Of those 129 patients screened, 48 (37%) were excluded due to negative KOH staining or cultures and 8 (6%) were excluded because onychomycosis was caused by nondermatophyte mold or yeast. At baseline, 73 (57%) patients who met the entry criteria were randomly allocated to receive 1 of 3 therapies for dermatophyte onychomycosis (3 treatment arms).|
- Relatively short treatment period for the toenail onychomycosis (9 months).
- Patients with total dystrophic onychomycosis (46%) - the most difficult subtype to treat - may not have been amenable to monotherapy with a topical antifungal treatment.