Sohag faculty of medicine
Sohag, Egypt
NCT Number: NCT06980493
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
This study is active but is not currently recruiting participants.
Notify Me0 day–16 year
All sexes
Interventional
Phase 2 / Phase 3
Sohag, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 4 months
Sohag University
Other
Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis
Acronym: prospective
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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