A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
Recruiting now · Not applicable
Conditions studied: Tinea Corporis, Tinea Cruris
In brief
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.
Key facts
- Study ID
- NCT07312604
- Run by
- Abeer Mohamed Abdelaziz Elkholy
- People needed
- 50
- Starts
- 2025-12-09
- Expected to finish
- 2026-03-09
- Last updated by the study team
- 2025-12-31
Who can join
Age: 10 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Mansoura University Hospital — Al Mansurah, Dakahlia Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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