Antifungal Drugs in Treatment of Onychomycosis
Primary Purpose
Antifungal Drugs in Onychomycosis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Terbinafine
Sponsored by
About this trial
This is an interventional treatment trial for Antifungal Drugs in Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Patients with finger nail onychomycosis of different sex and age.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Terbinafine group
Fluconazole group
Itraconazole group
Arm Description
Arm (1) will receive Terbinafine (250mg/day for 6 weeks).
Arm (2) will receive Fluconazole (300mg once weekly for 3monthes).
Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)
Outcomes
Primary Outcome Measures
cure rate of patients
Percentage of patients with complete cure in every group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171584
Brief Title
Antifungal Drugs in Treatment of Onychomycosis
Official Title
Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Onychomycosis accounts for up to 30% of all superficial infections of skin and constitutes about a half of all nail abnormalities; affecting approximately 5% of population worldwide
The prevalence of onychomycosis is determined by age, social class, occupation, climate, living environment and frequency of travel Despite being common dermatological presentation, the exact prevalence of onychomycosis remains largely unknown.
Toenails are more commonly affected than fingernails due to slower rate of growth of the former, reduced blood supply and usual confinement in dark moist environments The infection is more common in adult males (particularly elderly > 60 yrs of age), diabetics, immunocompromised individuals (e.g. HIV positive), individuals with peripheral vascular (arterial) disease, previous tineapedis infection, history of trauma to the nail, or those with a family history of onychomycosis Dermatophytes whether pathogenic or saprophytes are the commonest causative nail invaders Dermatophytic onychomycosis can be divided into four major clinical types on the basis of their presenting clinical features; distal and lateral subungualonychomycosis (DLSO), proximal subungualonychomycosis (PSO), white superficial onychomycosis (WSO) and total dystrophic onychomycosis (TDO) , Among these,distal and lateral subungualonychomycosis( DLSO) is the most common form.
Clinical diagnosis by physical examination alone can be inaccurate as many non infectious conditions that mimic onychomycosis like lichen planus, psoriasis need to be ruled out . Various laboratory techniques have been used to accurately diagnose onychomycosis, with microscopy by KOH and fungal culture being the most frequently used The histopathology of nail clippings can be utilized for diagnosing onychomycosis, with periodic acid-Schiff (PAS) stain that allows easy visualization of fungal hyphae . Digital dermoscopy, also called onychoscopy, is an easy and quick procedure that allows differential diagnosis of onychomycosis from the common nail dystrophies.
Dystrophic nails can be a social impediment causing significant embarrassment that affects patient's self-esteem. In addition, thickened nails can be painful, interfere with the function of the nail unit and may cause discomfort in walking, standing and exercising.
Though initially presenting as a cosmetic problem, it can eventually lead to permanent disfigurement of the nails and serve as a source of other fungal infections . Due to these significant effects specific questionnaire was designed and validated to assess quality of life in patients with onychomycosis
Treatment is chosen depending on the modality of nail invasion, fungus species and the number of affected nails. Oral treatments are often limited by drug interactions, while topical antifungal lacquers have less efficacy . Surgery or nail debridement is another invasive treatment option in limited resistant cases .
The use of griseofulvin and ketoconazole is problematic, as there are typically high relapse rates of 50-85%. In addition, treatment must be continued for a long duration with risky systemic side effects.
Fluconazole, itraconazole and terbinafine are relatively safe antifungal drugs that have been widely used with improved treatment success, producing a mycological cure in more than 90% of fingernail infections and in about 80% of toenail infections
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antifungal Drugs in Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Terbinafine group
Arm Type
Experimental
Arm Description
Arm (1) will receive Terbinafine (250mg/day for 6 weeks).
Arm Title
Fluconazole group
Arm Type
Experimental
Arm Description
Arm (2) will receive Fluconazole (300mg once weekly for 3monthes).
Arm Title
Itraconazole group
Arm Type
Experimental
Arm Description
Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)
Intervention Type
Drug
Intervention Name(s)
Terbinafine
Other Intervention Name(s)
Fluconazole, Itraconazole
Intervention Description
oral antifungal drugs
Primary Outcome Measure Information:
Title
cure rate of patients
Description
Percentage of patients with complete cure in every group
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with finger nail onychomycosis of different sex and age.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Abd El-raheem Taha, MD
Phone
01006462294
Email
emadtaha76@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa Mohamed Bakr
Phone
01119988115
Email
radwabakr2011@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24352873
Citation
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.
Results Reference
result
PubMed Identifier
22565425
Citation
Grover 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.
Results Reference
result
PubMed Identifier
14964746
Citation
Gupta AK, Ryder JE, Summerbell RC. Onychomycosis: classification and diagnosis. J Drugs Dermatol. 2004 Jan-Feb;3(1):51-6.
Results Reference
result
PubMed Identifier
19968146
Citation
Neupane S, Pokhrel DB, Pokhrel BM. Onychomycosis: a clinico-epidemiological study. Nepal Med Coll J. 2009 Jun;11(2):92-5.
Results Reference
result
PubMed Identifier
24079585
Citation
Wulkan AJ, Tosti A. Pediatric nail conditions. Clin Dermatol. 2013 Sep-Oct;31(5):564-72. doi: 10.1016/j.clindermatol.2013.06.017.
Results Reference
result
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Antifungal Drugs in Treatment of Onychomycosis
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