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

Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Abeer Mohamed Abdelaziz Elkholy · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinea Corporis
• Tinea Cruris

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-03-09
• Completion: 2026-03-09
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Egypt