NCT07312604 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abeer Mohamed Abdelaziz Elkholy |
| Condition | Tinea Corporis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-03-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-12-09 with a primary completion date of 2026-03-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. \*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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312604 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 60 Years, studying Tinea Corporis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07312604 currently recruiting?
Yes, NCT07312604 is actively recruiting participants. Contact the research team at abeerkholy@hotmail.com for enrollment information.
Where is the NCT07312604 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07312604 clinical trial?
NCT07312604 is sponsored by Abeer Mohamed Abdelaziz Elkholy. The trial plans to enroll 50 participants.