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)

December 17, 2025 updated by: Abeer Mohamed Abdelaziz Elkholy

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abeer Mohamed Elkholy, MD degree of Dermatology
  • Phone Number: +201006210646
  • Email: abeerkholy@hotmail.com

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-Lesional Immunotherapy
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
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.
Other Names:
  • Priorix®
  • MMR Vaccine
  • Measles-Mumps-Rubella Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent reduction in affected body surface area (BSA) from baseline
Time Frame: Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.
The primary efficacy endpoint is the percent reduction in the total body surface area affected by recalcitrant tinea (cruris and/or corporis), assessed by clinical examination at each study visit. This measure evaluates the improvement in lesion extent and treatment response over time.
Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability: Incidence and severity of treatment-emergent adverse events
Time Frame: Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.
All adverse events (AEs) occurring during the study including injection site reactions, fever or initial flare, increased pruritus as well as severe reactions (anaphylaxis or angioedema) will be systematically monitored and recorded.
Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abeer Mohamed Abdelaziz Elkholy

Collaborators

Mansoura University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

March 9, 2026

Study Completion (Estimated)

March 9, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.25.11.3446

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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