Antifungal Drugs in Treatment of Onychomycosis

May 28, 2017 updated by: AMLadeed, Assiut University

Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure rate of patients
Time Frame: one year
Percentage of patients with complete cure in every group
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 28, 2017

First Posted (ACTUAL)

May 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 28, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oncho

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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