Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

NCT06400056 | Not Yet Recruiting Phase 1

• 1 other identifier: Fungal resistance
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

AIM OF WORK :

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

Conditions

Fungal Resistance

Outcome Measures

Primary Outcomes (2)

• -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.

  Baseline

• Resistant strain in tinea capitis

  \- Detect the resistant strain by using culture of scrapped sample.

  Baseline

Study Arms (1)

Terbinafine

EXPERIMENTAL

Patients 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

Drug: Terbinafine

Interventions

Terbinafine DRUG

FDA approved

Terbinafine

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 34459941 BACKGROUND

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

  PMID: 30215902 BACKGROUND

• 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.

  PMID: 35205940 BACKGROUND

• 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.

  PMID: 35330222 RESULT

MeSH Terms

Interventions

Terbinafine

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Alaa Moubasher, Professor

  Supervisor

  STUDY DIRECTOR

• Radwa Bakr, Professor

  Supervisor

  STUDY DIRECTOR

Central Study Contacts

Reem Atef Ibrahim, M,B,B,CH

CONTACT

01097654229; reematef1993@gmail.com

Reem Atef Ibrahim, Resident

CONTACT

01097654229; reematef1993@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Model Details: More than 4 years old

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: May 6, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share