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Fungal ResistancePhase 1NCT06400056

Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

A Phase 1 study testing Terbinafine in people with Fungal Resistance, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

AIM OF WORK : 1. Detect the most common fungal strains that cause tinea capitis 2. Detect Different effectiveness of terbinafine in different cases 3. Detect the resistant strains. 4. Detect the mycological and the clinical cure rates upon using systemic terbinafine in treatment of tinea capitis Read more about this study

Who is it for?
Ages 4 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Fungal Resistance
What is being tested?
Terbinafine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
May 2024to May 2025
Phase
Phase 1
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 4 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • patients from both sexes aged > 4 years old.
  • patients have tinea capitis (scaly type)

Who cannot join

  • Patients have other types of tinea capitis infection.
  • Patients with heart valve diseases , Hearing loss , liver or kidney diseases.
  • Pregnant or lactating females.
  • Personal or family history of malignancy.
  • Immunocompramised patients.

Trial locations and contacts

No sites are listed yet.

Reem Atef Ibrahim, M,B,B,CH contact

01097654229

reematef1993@gmail.com

Reem Atef Ibrahim, Resident contact

01097654229

reematef1993@gmail.com

About this study

AIM OF WORK :

  1. Detect the most common fungal strains that cause tinea capitis
  2. Detect Different effectiveness of terbinafine in different cases
  3. Detect the resistant strains.
  4. Detect the mycological and the clinical cure rates upon using systemic terbinafine in treatment of tinea capitis
Read the detailed description

Introduction:

  • Tinea capitis is a superficial fungal infection of the skin of the scalp, with a propensity for attacking hair shafts and follicles . The disease is considered to be a form of superficial mycosis or dermatophytosis
  • It may affect all or part of the child's scalp.
  • Mold-like fungi called dermatophytes cause tinea capitis ,It is caused primarily by Dermatophyte species Microsporm and trichopyton,, In Egypt, dermatophytes called Microsporum canis and Microsporum audouinii are the most common causes of the infection. Fungi thrive in warm, moist environments. It commonly grows in tropical places.
  • Tinea capitis can be divided into inflammatory and non-inflammatory types, the non-inflammatory type usuallywill not be complicated by scaring alopecia , the inflammatory type may result in Kerion ,a painful nodule with pus and scaring alopecia, The clinical manifestations of tinea capitis are classified as endothrix, ectothrix, or favus. In the endothrix form, hyphae grow down the follicle and penetrate the hair shaft, then grow completely within the hair shaft. This form is caused predominantly by T. tonsurans and T. violaceum In the ectothrix form, the hyphae invade the hair shaft at mid follicle. Afterwards, hyphae grow out of the follicle covering the hair surface. This form is caused by M. canis, M. audouinii, Microsporum ferrugineum, and Trichophyton verrucosum. The hyphae grow parallel to the hair shaft in favus form then degenerate, leaving long tunnels within the hair shaft. Favus form is caused by Trichophyton schoenleinii and is characterized by yellow crust around the hair shafts and can result in permanent scarring alopecia.
  • ♦ Tinea capitis also spreads very easily. The patients can catch the infection from contact with infected people, animals and soil. They can also get it by using objects and touching surfaces that harbor the fungus. Tinea capitis can live for a long time on infected objects and surfaces. It is very contagious and can spread quickly among children
  • The diagnosis is suspected primarily clinically based on the appearance of the scalp lesion. A Wood's lamp test performed to confirm the presence of a fungal scalp infection , Dermoscopy is a useful and non invasive diagnostic tool which aids in the diagnosis of tinea capitis ,the diagnosis can be confirmed by microscopic examination of KOH,
  • Fungal culture is the gold standard to diagnose dermatophytosis,
  • fungal culture can help to differentiate fungal species
  • The treatment of tinea capitis requires systemic antifungal therapy because topical antifungal agents cannot penetrate the hair shaft sufficiently to eradicate infection. Griseofulvin, the former gold standard agent, has been associated with treatment failure; a retrospective review of patients' medical records revealed a failure rate of 39.3% , in octobr 2007 The FDA has approved terbinafine oral granules (Lamisil), which can be sprinkled on food, for tinia capitis in children four years and older , fluconazole and Itraconazole also used in treatment of Tinea capitis although they are not FDA approved
  • In the past few years , Numerous cases of tinea capitis that was initially resistant to systemic antifungal or recurred rapidly after a brief interval improvement recently have been seen
  • In general, clinical resistance is considered to be the persistence or progression of an infection despite appropriate antimicrobial therapy , This resistance can be attributed to a combination of factors related to the host, the antifungal agent, or the pathogen .
Being tested
Terbinafine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TerbinafineDrug

    FDA approved

Study groups in NCT06400056
Study groupRoleWhat they receive
TerbinafineExperimentalPatients will be treated by systemic terbinafine alone for 6 weeks • Dosage: 25 kg for 125 mg 25-35 kg for 187.5 mg 35 for 250 mg
Receives: Drug: Terbinafine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. -Detect the most common Fungal strains that cause tinea capitis

    • Detect the most common Fungal strains that cause tinea capitis by doing :
    • Fungal culture after gentle scraping of surface of affected area.

    Measured: Baseline

  2. Resistant strain in tinea capitis

    • Detect the resistant strain by using culture of scrapped sample.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

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 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
More than 4 years old
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06400056
Sponsor's protocol ID
Fungal resistance
Status last verified
May 2024
First submitted
18 Mar 2023
Last updated
6 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Appelt L, Nenoff P, Uhrlass S, Kruger C, Kuhn P, Eichhorn K, Buder S, Beissert S, Abraham S, Aschoff R, Bauer A. [Terbinafine-resistant dermatophytoses and onychomycosis due to Trichophyton rubrum]. Hautarzt. 2021 Oct;72(10):868-877. doi: 10.1007/s00105-021-04879-1. Epub 2021 Aug 30. German.

    PubMed 34459941
  • Hawks MK, Rupert JP, Svarverud JE. Terbinafine for Onychomycosis. Am Fam Physician. 2018 Aug 1;98(3):Online. No abstract available.

    PubMed 30215902
  • Lian LD, Shi LY, Zhu J, Liu R, Shi L, Ren A, Yu HS, Zhao MW. GlSwi6 Positively Regulates Cellulase and Xylanase Activities through Intracellular Ca2+ Signaling in Ganoderma lucidum. J Fungi (Basel). 2022 Feb 14;8(2):187. doi: 10.3390/jof8020187.

    PubMed 35205940
  • Moreno-Sabater A, Normand AC, Bidaud AL, Cremer G, Foulet F, Brun S, Bonnal C, Ait-Ammar N, Jabet A, Ayachi A, Piarroux R, Botterel F, Houze S, Desoubeaux G, Hennequin C, Dannaoui E. Terbinafine Resistance in Dermatophytes: A French Multicenter Prospective Study. J Fungi (Basel). 2022 Feb 23;8(3):220. doi: 10.3390/jof8030220.

    PubMed 35330222

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Terbinafine in people with Fungal Resistance, 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 2 inclusion and 5 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 6 May 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Reem Atef Ibrahim, M,B,B,CH (01097654229, reematef1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

-Detect the most common Fungal strains that cause tinea capitis (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06400056, which also lists 4 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 6 May 2024.

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