A Phase 2/3 interventional study of Amphotericine in liposome (Ambisome®) in Tinea Capitis, sponsored by Sohag University. Active, not recruiting at 1 site in Egypt. Open to participants aged 0 Days to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Sohag University · Phase 2/3, Interventional, and Treatment
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
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 .
Patient and method After approval of the study by Research and Ethical committee at Sohag faculty of medicine, this study will include group of patients attending the outpatient clinic of Dermatology, venereology and andrology department in Sohag university hospital.
An informed written consent will be obtained from parents of all participants after full explanation of the procedure.
Inclusion criteria:
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.
Study design : prospective clinical study. Sample Size : 30 participants.
Exclusion criteria:
Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.
method All recruited children will be submitted to clinical assessment as follows
Clinical examination:
Description of the lesion (site, size, shape, presence of scales, loss of hair or Lymphadenopathy).
Dermoscopic examination:
Dermoscopic features of tinea capitis non inflammatory type includes
Procedure:
Preparation Prepare a 2.5% amphotericin B solution by reconstitute liposomal amphotericin B 50 mg vial in 20 ml distilled water result in a final concentration of 2.5 mg/ml. The resulting solution will be stored in bottles with a dropper and protected from light with aluminum foil.
Application Patients apply the solution to each affected area and briefly let the solution evaporate.
Frequency: Apply once daily. Duration: Continue treatment for 8 weeks or until clinical resolution with dermoscopic confirmation.
Treatment Protocol Baseline assessment. Perform a thorough clinical assessment. Instruct patients/guardians on proper application techniques. Schedule weekly follow-ups for 8 weeks. Monitoring
Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®)
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
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)
Time frame: 4 months
Plan to share: Yes — result of the study
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal amphotericin B
Tinea Capitis