A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
NCT ID: NCT07312604
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-09
2026-03-09
Brief Summary
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\*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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intra-Lesional Immunotherapy
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
Intra-Lesional MMR Immunotherapy
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.
Interventions
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Intra-Lesional MMR Immunotherapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Age \<10 years or \> 60 years.
* Immunocompromised patients e.g. (uncontrolled DM or HIV patients).
* Naïve patients without previous systemic antifungal treatment.
* Unreliable patients.
10 Years
60 Years
ALL
No
Sponsors
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Abeer Mohamed Abdelaziz Elkholy
OTHER
Mansoura University Hospital
OTHER
Responsible Party
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Abeer Mohamed Abdelaziz Elkholy
Professor of Dermatology, Faculty of Medicine, Mansoura University
Locations
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Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Abeer Mohamed Elkholy, MD degree of Dermatology
Role: CONTACT
Phone: +201006210646
Email: [email protected]
Nora Mohamed Abdelrazik, MD degree of Dermatology
Role: CONTACT
Phone: +201060291029
Email: [email protected]
Facility Contacts
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Ahmed Ibrahim Ali, Master degree of Dermatology
Role: primary
Other Identifiers
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R.25.11.3446
Identifier Type: -
Identifier Source: org_study_id