Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study is conducted to corroborate the previous observational clinical trial with more valid methods and a more clinically relevant experimental design. This study aims to compare efficacy, safety, and cost between topically administered 30% resin lacquer for the treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5% amorolfine and systemic terbinafine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborator: Repolar Ltd.
• Treatments: Amorolfine; Terbinafine

Criteria

Inclusion Criteria:

• Positive dermatophyte culture in the beginning of the study obtained from the toenail sample.

• Positive KOH stain in the beginning of the study obtained from the toenail sample.

Exclusion Criteria:

• Any other nail disease than dermatophyte culture or KOH stain verified onychomycosis

• Onychomycosis caused by yeasts or nondermatophyte molds

• Kidney failure determined by plasma creatinine level (P-Krea > 100 μmol/l)

• Liver failure determined by plasma γ-glutamyltransferase level (P-GT > 120 U/I)

• Sensitivity or allergy to Resin, Amorolfine or Terbinafine

• Potential adverse cross-reaction of Terbinafine, Amorolfine or Resin with the patient's permanent medication

• Presence of total dystrophic onychomycosis (TDO)

• Any topical or oral antifungal treatment within the 6 months before the beginning of the study (washout period > 6 months).