Antifungal Drugs in OnychomycosisPhase 3NCT03171584
Antifungal Drugs in Treatment of Onychomycosis
A Phase 3 study testing Terbinafine in people with Antifungal Drugs in Onychomycosis, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Antifungal Drugs in Onychomycosis
- What is being tested?
- Terbinafine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with finger nail onychomycosis of different sex and age.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Antifungal Drugs in Onychomycosis
- Being tested
- Terbinafine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbinafineDrug
Also called Fluconazole, Itraconazole
oral antifungal drugs
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine group | Experimental | Arm (1) will receive Terbinafine (250mg/day for 6 weeks). Receives: Drug: Terbinafine |
| Fluconazole group | Experimental | Arm (2) will receive Fluconazole (300mg once weekly for 3monthes). Receives: Drug: Terbinafine |
| Itraconazole group | Experimental | Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail) Receives: Drug: Terbinafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate of patients
Percentage of patients with complete cure in every group
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Antifungal Drugs in OnychomycosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMLadeed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171584
- Sponsor's protocol ID
- oncho
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24352873Grover 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.
PubMed 22565425Gupta AK, Ryder JE, Summerbell RC. Onychomycosis: classification and diagnosis. J Drugs Dermatol. 2004 Jan-Feb;3(1):51-6.
PubMed 14964746Neupane S, Pokhrel DB, Pokhrel BM. Onychomycosis: a clinico-epidemiological study. Nepal Med Coll J. 2009 Jun;11(2):92-5.
PubMed 19968146Wulkan AJ, Tosti A. Pediatric nail conditions. Clin Dermatol. 2013 Sep-Oct;31(5):564-72. doi: 10.1016/j.clindermatol.2013.06.017.
PubMed 24079585
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT03171584
- Acronym / sponsor ID
- oncho
- Conditions
- Antifungal Drugs in Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terbinafine group | Experimental | Drug: TerbinafineArm (1) will receive Terbinafine (250mg/day for 6 weeks). |
| Fluconazole group | Experimental | Drug: TerbinafineArm (2) will receive Fluconazole (300mg once weekly for 3monthes). |
| Itraconazole group | Experimental | Drug: TerbinafineArm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with finger nail onychomycosis of different sex and age.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerbinafineAlso: Fluconazole, Itraconazoleoral antifungal drugs | Drug | Fluconazole group, Itraconazole group, Terbinafine group |
Primary outcome
cure rate of patients
Time frame: one year
Percentage of patients with complete cure in every group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Results publication: PubMed 24352873de 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 publication: PubMed 22565425Grover 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 publication: PubMed 14964746Gupta AK, Ryder JE, Summerbell RC. Onychomycosis: classification and diagnosis. J Drugs Dermatol. 2004 Jan-Feb;3(1):51-6.
- Results publication: PubMed 19968146Neupane S, Pokhrel DB, Pokhrel BM. Onychomycosis: a clinico-epidemiological study. Nepal Med Coll J. 2009 Jun;11(2):92-5.
- Results publication: PubMed 24079585Wulkan AJ, Tosti A. Pediatric nail conditions. Clin Dermatol. 2013 Sep-Oct;31(5):564-72. doi: 10.1016/j.clindermatol.2013.06.017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terbinafine in people with Antifungal Drugs in Onychomycosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emad Abd El-raheem Taha, MD (01006462294, emadtaha76@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate of patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171584, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.