Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working

NCT06980493 | Active Not Recruiting Phase 2

• 1 other identifier: Soh-Med-25-1-04MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if topical amphotericin b solution works to treat resistant cases of tinea capitis in children. It will also learn about the safety of drug. The main questions it aims to answer are: Does amphotericin b solution effective in cases not cured by systemic antifungal tab? Participants will: use topical amphotericin b solution every day for8 weeks Visit the clinic once every 1 week for follow up then follow up after 1 month and fungal culture will be done to test if the treatment working

Conditions

Tinea Capitis

Keywords

topical amphotericin b solution in tinea capitis

Outcome Measures

Primary Outcomes (1)

• monitoring for reduction in size of scaling weekly for 8 weeks

  • children 16 years old or less will be evaluated to detect an effect size of 0.3 in the rate of the disease improvement (reduction in scaling) on repeated measurements (follow up weekly for 8 weeks)

  4 months

Study Arms (1)

amphotericin b topical solution

ACTIVE COMPARATOR

evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment .

Drug: Amphotericine in liposome (Ambisome®)

Interventions

Amphotericine in liposome (Ambisome®) DRUG

The aim of the study will be to evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment

amphotericin b topical solution

Eligibility Criteria

• Age: 0 Days - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged \< 16 years affected by tinea capitis non inflammatory type who are clinically and dermoscopically confirmed after resistant response to oral systemic treatment for 8 weeks.

You may not qualify if:

• Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Tinea Capitis

Interventions

Liposomes; liposomal amphotericin B

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Scalp Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 20, 2025
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)