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Antifungal Drugs in Treatment of Onychomycosis

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ClinicalTrials.gov Identifier: NCT03171584
Recruitment Status : Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
AMLadeed, Assiut University

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

Condition or disease Intervention/treatment Phase
Antifungal Drugs in Onychomycosis Drug: Terbinafine Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Terbinafine group
Arm (1) will receive Terbinafine (250mg/day for 6 weeks).
Drug: Terbinafine
oral antifungal drugs
Other Names:
  • Fluconazole
  • Itraconazole

Experimental: Fluconazole group
Arm (2) will receive Fluconazole (300mg once weekly for 3monthes).
Drug: Terbinafine
oral antifungal drugs
Other Names:
  • Fluconazole
  • Itraconazole

Experimental: Itraconazole group
Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)
Drug: Terbinafine
oral antifungal drugs
Other Names:
  • Fluconazole
  • Itraconazole




Primary Outcome Measures :
  1. cure rate of patients [ Time Frame: one year ]
    Percentage of patients with complete cure in every group



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171584


Contacts
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Contact: Emad Abd El-raheem Taha, MD 01006462294 emadtaha76@yahoo.com
Contact: Radwa Mohamed Bakr 01119988115 radwabakr2011@hotmail.com

Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: AMLadeed, A comparative Study of Systemic antifungal drugs used in treatment of onychomycosis, Assiut University
ClinicalTrials.gov Identifier: NCT03171584     History of Changes
Other Study ID Numbers: oncho
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Itraconazole
Hydroxyitraconazole
Fluconazole
Antifungal Agents
Miconazole
Terbinafine
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors