Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location status: Recruiting

Location contact

Ahmed Ibrahim Ali, Master degree of Dermatology

CONTACT

[email protected]

+201011442104

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-Lesional MMR Immunotherapy

Biological

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: MMR Vaccine, Measles-Mumps-Rubella Vaccine, Priorix®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer Mohamed Elkholy, MD degree of Dermatology

CONTACT

[email protected]

+201006210646

Nora Mohamed Abdelrazik, MD degree of Dermatology

CONTACT

[email protected]

+201060291029

Sponsors and collaborators

Lead sponsor

Abeer Mohamed Abdelaziz Elkholy

Other

Collaborators

  • Mansoura University Hospital

Registry information

Official study title

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

Acronym: IL-ImmuneRTC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.