Tinea CapitisPhase 2/3prospectiveNCT06980493
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
A Phase 2/3 study testing Amphotericine in liposome (Ambisome®) in people with Tinea Capitis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Amphotericine in liposome (Ambisome®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis
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
Read the detailed description
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
- Personal history: name, age, sex, residence.
- Family history of similar condition.
- Medical history: received systemic antifungal treatment type, dose and for how long.
- Laporatory investigation :CBC and liver function test.
- Complete general examination. To exclude any systemic diseases.
- Dermatological examination:
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
- Comma hairs (short hairs that bend and grow back toward the scalp,resembling a comma)
- Corkscrew hairs (short hairs that are coiled up like a corkscrew)
- Zigzag hairs (short hairs with several bends in them like a zigzag pattern)
- Morse code-like .
- Bent hairs.
- Scales, follicular keratosis, and crusts -Erythema -Broken hairs -Black dots.
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
- Monitor for clinical signs of improvement: reduction in itching, scaling and hair regrowth Weekly for 8 weeks then follow up after 1 month with dermoscopic photographing .
- A fungal culture test will be done in follow up visit after 1 month to test if the treatment is working.
- follow up monitor for side effects: local irritation, redness or systemic reactions
- Conditions
- Tinea Capitis
- Being tested
- Amphotericine in liposome (Ambisome®)
- Keywords
- topical amphotericin b solution in tinea capitis
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Drug: Amphotericine in liposome (Ambisome®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Alkassem Nour, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980493
- Sponsor's protocol ID
- Soh-Med-25-1-04MS
- Acronym
- prospective
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: result of the study
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis
- ClinicalTrials.gov ID
- NCT06980493
- Acronym / sponsor ID
- prospective / Soh-Med-25-1-04MS
- Conditions
- Tinea Capitis
- Keywords
- topical amphotericin b solution in tinea capitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
- Personal history: name, age, sex, residence.
- Family history of similar condition.
- Medical history: received systemic antifungal treatment type, dose and for how long.
- Laporatory investigation :CBC and liver function test.
- Complete general examination. To exclude any systemic diseases.
- Dermatological examination:
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
- Comma hairs (short hairs that bend and grow back toward the scalp,resembling a comma)
- Corkscrew hairs (short hairs that are coiled up like a corkscrew)
- Zigzag hairs (short hairs with several bends in them like a zigzag pattern)
- Morse code-like .
- Bent hairs.
- Scales, follicular keratosis, and crusts -Erythema -Broken hairs -Black dots.
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
- Monitor for clinical signs of improvement: reduction in itching, scaling and hair regrowth Weekly for 8 weeks then follow up after 1 month with dermoscopic photographing .
- A fungal culture test will be done in follow up visit after 1 month to test if the treatment is working.
- follow up monitor for side effects: local irritation, redness or systemic reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amphotericin b topical solution | Active comparator | Drug: Amphotericine in liposome (Ambisome®)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 . |
Who may qualify
- Ages
- 0 days to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | amphotericin b topical solution |
Primary outcome
monitoring for reduction in size of scaling weekly for 8 weeks
Time frame: 4 months
• 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. result of the study
Related trials for Tinea Capitis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children
Fungal Infection by Site, Tinea Capitis
Recruiting
Comparison Between Continuous and Pulse Itraconazole in Tinea Capitis in Children
Tinea Capitis
RecruitingObservational study
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Tinea Capitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amphotericine in liposome (Ambisome®) in people with Tinea Capitis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monitoring for reduction in size of scaling weekly for 8 weeks (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.