Tinea CorporisIL-ImmuneRTCNCT07312604
A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
A study testing Intra-Lesional MMR Immunotherapy in people with Tinea Corporis and Tinea Cruris, run by Abeer Mohamed Abdelaziz Elkholy at 1 site in Egypt.
Trial summary
This pilot study will test intra-lesional immunotherapy (MMR vaccine) injections as a treatment for recalcitrant tinea cruris and corporis in patients aged 10-60 years who have not improved with standard antifungal treatments. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Tinea Corporis, Tinea Cruris
- What is being tested?
- Intra-Lesional MMR Immunotherapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Dec 2025to 9 Mar 2026
- Phase
- Interventional
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 - 60 years.
- Evidence of recalcitrant tinea e.g. (rapid progression \& large areas affected of the body, affection of more than one family members especially females \& children, rapid relapse after treatment, suspicion of resistant T. indotineae strain by history of traveling abroad \& contact with Indians or contact with a case coming from travel \& with contact to Indians.
- Patients failed at least 2 courses of systemic antifungal therapy in the last 3 months.
- Safe contraception during the study (for females in the childbearing period).
Who cannot join
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- Age <10 years or > 60 years.
- Immunocompromised patients e.g. (uncontrolled DM or HIV patients).
- Naïve patients without previous systemic antifungal treatment.
- Unreliable patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35511
Ahmed Ibrahim Ali, Master degree of Dermatology, +201011442104, Ahmed.abdelhadi@med.suezuni.edu.eg
About this study
Official title: Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study
This pilot study will test intra-lesional immunotherapy (MMR vaccine) injections as a treatment for recalcitrant tinea cruris and corporis in patients aged 10-60 years who have not improved with standard antifungal treatments.
*Eligibility: Participants must have recalcitrant tinea, defined as:
Read more
- Rapid progression or large areas of skin affected,
- Infection in multiple family members, especially females and children
- Rapid relapse after prior treatment
- Suspected resistant T. indotineae (based on travel history or contact with affected individuals from high-prevalence regions)
- Failure of at least 2 courses of systemic antifungal therapy in the past 3 months
Treatment: Patients will receive intra-lesional MMR vaccine injections into the active borders of affected lesions every 2 weeks for up to 6 weeks. If partial improvement occurs but complete clearance is not achieved, the course may be repeated for another 6 weeks. Pulse itraconazole will be given during the first 2 weeks.
Monitoring: At each study visit, clinicians will assess the extent of affected skin and monitor symptoms particularly itching. Safety will be closely observed, including injection-site reactions, fever, initial flare of lesions, and any rare serious allergic reactions.
Goal: To evaluate the safety and effectiveness of intra-lesional MMR immunotherapy for patients with tinea that has been difficult to treat.
- Conditions
- Tinea Corporis, Tinea Cruris
- Being tested
- Intra-Lesional MMR Immunotherapy
- Keywords
- Tinea Cruris, Tinea Corporis, Recalcitrant Dermatophytosis, Intra-Lesional Immunotherapy, Pilot Clinical Study, Dermatophyte Treatment
- Medical subject headings
- Tinea, Tinea Cruris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Lesional MMR ImmunotherapyBiological
Also called MMR Vaccine, Measles-Mumps-Rubella Vaccine, Priorix®
Participants will receive intra-lesional immunotherapy using the measles-mumps-rubella (MMR) vaccine. The vaccine will be injected into the active borders of affected lesions every 2 weeks for a total duration of 6 weeks. Clinical assessment of lesion extent and symptoms, particularly pruritus, will be performed at baseline and at each visit. If partial clinical improvement is observed after the initial 6 weeks but complete resolution is not achieved, the treatment course may be extended for an additional 6 weeks, with a maximum of six intra-lesional injection sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Lesional Immunotherapy | Experimental | All participants with recalcitrant tinea cruris and/or tinea corporis will receive intra-lesional immunotherapy. There is no comparator or placebo group. Male and female participants are included in the same arm and will be analyzed as subgroups.Intra-Lesional Immunotherapy Receives: Biological: Intra-Lesional MMR Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in affected body surface area (BSA) from baseline
The primary efficacy endpoint is the percent reduction in the total body surface area affected by recalcitrant tinea (cruris and/or corporis), assessed by clinical examination at each study visit. This measure evaluates the improvement in lesion extent and treatment response over time.
Measured: Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.
Secondary outcomes (1)
Safety and Tolerability: Incidence and severity of treatment-emergent adverse events
All adverse events (AEs) occurring during the study including injection site reactions, fever or initial flare, increased pruritus as well as severe reactions (anaphylaxis or angioedema) will be systematically monitored and recorded.
Measured: Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start9 Dec 2025
- Primary completion9 Mar 2026 (estimated)
- Study completion9 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CorporisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abeer Mohamed Abdelaziz Elkholy
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University Hospital
- Responsible party
- Sponsor-investigator, Abeer Mohamed Abdelaziz Elkholy, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312604
- Sponsor's protocol ID
- R.25.11.3446
- Acronym
- IL-ImmuneRTC
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study
- ClinicalTrials.gov ID
- NCT07312604
- Acronym / sponsor ID
- IL-ImmuneRTC / R.25.11.3446
- Conditions
- Tinea Corporis, Tinea Cruris
- Keywords
- Tinea Cruris, Tinea Corporis, Recalcitrant Dermatophytosis, Intra-Lesional Immunotherapy, Pilot Clinical Study, Dermatophyte Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abeer Mohamed Abdelaziz ElkholyUniversity, hospital or other
- Collaborators
- Mansoura University Hospital
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 9 Mar 2026 (estimated)
- First posted
- 31 Dec 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.
This pilot study will test intra-lesional immunotherapy (MMR vaccine) injections as a treatment for recalcitrant tinea cruris and corporis in patients aged 10-60 years who have not improved with standard antifungal treatments.
*Eligibility: Participants must have recalcitrant tinea, defined as:
- Rapid progression or large areas of skin affected,
- Infection in multiple family members, especially females and children
- Rapid relapse after prior treatment
- Suspected resistant T. indotineae (based on travel history or contact with affected individuals from high-prevalence regions)
- Failure of at least 2 courses of systemic antifungal therapy in the past 3 months
Treatment: Patients will receive intra-lesional MMR vaccine injections into the active borders of affected lesions every 2 weeks for up to 6 weeks. If partial improvement occurs but complete clearance is not achieved, the course may be repeated for another 6 weeks. Pulse itraconazole will be given during the first 2 weeks.
Monitoring: At each study visit, clinicians will assess the extent of affected skin and monitor symptoms particularly itching. Safety will be closely observed, including injection-site reactions, fever, initial flare of lesions, and any rare serious allergic reactions.
Goal: To evaluate the safety and effectiveness of intra-lesional MMR immunotherapy for patients with tinea that has been difficult to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-Lesional Immunotherapy | Experimental | Biological: Intra-Lesional MMR ImmunotherapyAll participants with recalcitrant tinea cruris and/or tinea corporis will receive intra-lesional immunotherapy. There is no comparator or placebo group. Male and female participants are included in the same arm and will be analyzed as subgroups.Intra-Lesional Immunotherapy |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 10 - 60 years.
- Evidence of recalcitrant tinea e.g. (rapid progression \& large areas affected of the body, affection of more than one family members especially females \& children, rapid relapse after treatment, suspicion of resistant T. indotineae strain by history of traveling abroad \& contact with Indians or contact with a case coming from travel \& with contact to Indians.
- Patients failed at least 2 courses of systemic antifungal therapy in the last 3 months.
- Safe contraception during the study (for females in the childbearing period).
Key exclusion criteria (5 listed)
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- Age <10 years or > 60 years.
- Immunocompromised patients e.g. (uncontrolled DM or HIV patients).
- Naïve patients without previous systemic antifungal treatment.
- Unreliable patients.
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 |
|---|---|---|
| Intra-Lesional MMR ImmunotherapyAlso: MMR Vaccine, Measles-Mumps-Rubella Vaccine, Priorix®Participants will receive intra-lesional immunotherapy using the measles-mumps-rubella (MMR) vaccine. The vaccine will be injected into the active borders of affected lesions every 2 weeks for a total duration of 6 weeks. Clinical assessment of lesion extent and symptoms, particularly pruritus, will be performed at baseline and at each visit. If partial clinical improvement is observed after the initial 6 weeks but complete resolution is not achieved, the treatment course may be extended for an additional 6 weeks, with a maximum of six intra-lesional injection sessions. | Biological | Intra-Lesional Immunotherapy |
Primary outcome
Percent reduction in affected body surface area (BSA) from baseline
Time frame: Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.
The primary efficacy endpoint is the percent reduction in the total body surface area affected by recalcitrant tinea (cruris and/or corporis), assessed by clinical examination at each study visit. This measure evaluates the improvement in lesion extent and treatment response over time.
1 secondary outcome
Safety and Tolerability: Incidence and severity of treatment-emergent adverse events
Time frame: Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.
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 31 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Lesional MMR Immunotherapy in people with Tinea Corporis and Tinea Cruris, run by Abeer Mohamed Abdelaziz Elkholy 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Dec 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.
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?
Contact Abeer Mohamed Elkholy, MD degree of Dermatology (+201006210646, abeerkholy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in affected body surface area (BSA) from baseline (time frame: Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.). 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 31 Dec 2025.