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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antifungal Drugs in Onychomycosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with finger nail onychomycosis of different sex and age.

Exclusion Criteria:

  1. Patients taking immunosuppressive drugs or drugs affecting nail colour or growth.
  2. Patients with previous trauma to the nails.
  3. Pregnant and lactating women.
  4. Patients with 20 nail dystrophy.
  5. Patients with keratinization disorders as psoriasis and chronic medical or cutaneous diseases.
  6. 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

    First Posted
    May 28, 2017
    Last Updated
    May 28, 2017
    Sponsor
    Assiut University
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    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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