Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:10 AM
Study NCT ID:
NCT07312604
Status:
RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
Sponsor:
Abeer Mohamed Abdelaziz Elkholy
Organization:
Study Overview
Official Title:
Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IL-ImmuneRTC
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: 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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: