A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis (IL-ImmuneRTC)

Abeer Mohamed Abdelaziz Elkholy

Status: Enrolling

Conditions: Tinea Cruris; Tinea Corporis

Treatments: Biological: Intra-Lesional MMR Immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07312604

R.25.11.3446

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intra-Lesional Immunotherapy

Experimental group

Description:

All participants with recalcitrant tinea cruris and/or tinea corporis will receive intra-lesional immunotherapy. There is no comparator or placebo group. Male and female participants are included in the same arm and will be analyzed as subgroups.Intra-Lesional Immunotherapy

Treatment:

Biological: Intra-Lesional MMR Immunotherapy