Actively Recruiting

Phase Not Applicable
Age: 10Years - 60Years
All Genders
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

Led by Abeer Mohamed Abdelaziz Elkholy · Updated on 2025-12-31

50

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

A

Abeer Mohamed Abdelaziz Elkholy

Lead Sponsor

M

Mansoura University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official 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

Who Can Participate

Age: 10Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 10 - 60 years
  • Recalcitrant tinea with rapid progression or large affected areas
  • Infection affecting more than one family member, especially females and children
  • Rapid relapse after prior treatment
  • Suspected resistant T. indotineae strain based on travel or contact history
  • Failure of at least 2 courses of systemic antifungal therapy in the last 3 months
  • Safe contraception during the study for females of childbearing potential
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women, or women of childbearing potential not using effective contraception
  • Age less than 10 years or greater than 60 years
  • Immunocompromised patients, such as those with uncontrolled diabetes or HIV
  • Patients without previous systemic antifungal treatment
  • Unreliable patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt, 35511

Actively Recruiting

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Research Team

A

Abeer Mohamed Elkholy, MD degree of Dermatology

CONTACT

N

Nora Mohamed Abdelrazik, MD degree of Dermatology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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