Antifungal Drugs in Treatment of Onychomycosis
Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Onychomycosis refers to the fungal infection of the fingernails or toenails, caused by dermatophytes, yeast and non-dermatophyte molds that lead to distortion, discoloration, thickening and detachment from the nail bed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedMay 31, 2017
May 1, 2017
1.9 years
May 28, 2017
May 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
cure rate of patients
Percentage of patients with complete cure in every group
one year
Study Arms (3)
Terbinafine group
EXPERIMENTALArm (1) will receive Terbinafine (250mg/day for 6 weeks).
Fluconazole group
EXPERIMENTALArm (2) will receive Fluconazole (300mg once weekly for 3monthes).
Itraconazole group
EXPERIMENTALArm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)
Interventions
oral antifungal drugs
Eligibility Criteria
You may qualify if:
- Patients with finger nail onychomycosis of different sex and age.
You may not qualify if:
- Patients taking immunosuppressive drugs or drugs affecting nail colour or growth.
- Patients with previous trauma to the nails.
- Pregnant and lactating women.
- Patients with 20 nail dystrophy.
- Patients with keratinization disorders as psoriasis and chronic medical or cutaneous diseases.
- Patients with chronic medical or cutaneous diseases that may affect quality of life.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
de Sa DC, Lamas AP, Tosti A. Oral therapy for onychomycosis: an evidence-based review. Am J Clin Dermatol. 2014 Feb;15(1):17-36. doi: 10.1007/s40257-013-0056-2.
PMID: 24352873RESULTGrover C, Khurana A. Onychomycosis: newer insights in pathogenesis and diagnosis. Indian J Dermatol Venereol Leprol. 2012 May-Jun;78(3):263-70. doi: 10.4103/0378-6323.95440.
PMID: 22565425RESULTGupta AK, Ryder JE, Summerbell RC. Onychomycosis: classification and diagnosis. J Drugs Dermatol. 2004 Jan-Feb;3(1):51-6.
PMID: 14964746RESULTNeupane S, Pokhrel DB, Pokhrel BM. Onychomycosis: a clinico-epidemiological study. Nepal Med Coll J. 2009 Jun;11(2):92-5.
PMID: 19968146RESULTWulkan AJ, Tosti A. Pediatric nail conditions. Clin Dermatol. 2013 Sep-Oct;31(5):564-72. doi: 10.1016/j.clindermatol.2013.06.017.
PMID: 24079585RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A comparative Study of Systemic antifungal drugs used in treatment of onychomycosis
Study Record Dates
First Submitted
May 28, 2017
First Posted
May 31, 2017
Study Start
July 1, 2017
Primary Completion
June 1, 2019
Study Completion
November 1, 2019
Last Updated
May 31, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share