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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag faculty of medicine | Sohag | Egypt |
result of the study
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| ID | Term |
|---|---|
| D014006 | Tinea Capitis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012536 | Scalp Dermatoses |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008081 | Liposomes |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D008567 | Membranes, Artificial |
| D001697 | Biomedical and Dental Materials |
| D004337 | Drug Carriers |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D040761 | Biomimetic Materials |
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