drugset / Trial / 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

NCT07312604

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-09
Primary completion
2026-03-09
Completion
2026-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject M-M-R II Vaccine Other