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RecruitingNCT07312604IL-ImmuneRTCUpdated Dec 31, 2025

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

An interventional study of Intra-Lesional MMR Immunotherapy in Tinea Corporis and Tinea Cruris, sponsored by Abeer Mohamed Abdelaziz Elkholy. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Abeer Mohamed Abdelaziz Elkholy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
10 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tinea Corporis
  • Tinea Cruris

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Keywords

  • Tinea Cruris
  • Tinea Corporis
  • Recalcitrant Dermatophytosis
  • Intra-Lesional Immunotherapy
  • Pilot Clinical Study
  • Dermatophyte Treatment
03

In context

Tinea

39 studies on the registry are indexed under Tinea; 8 are open to participants now.

This study's planned enrollment of 50 is below the median of 64 across 33 interventional studies indexed under Tinea.

Browse Tinea studies →

Lead sponsor

This is the only study on the registry with Abeer Mohamed Abdelaziz Elkholy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 during the study (for females in the childbearing period).

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women, as well as women of not using an effective method of .
  • Age \<10 years or > 60 years.
  • patients e.g. (uncontrolled DM or patients).
  • Naïve patients without previous systemic antifungal treatment.
  • Unreliable patients.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • 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.

    Also known as: MMR Vaccine, Measles-Mumps-Rubella Vaccine, Priorix®

06

What researchers measure

Primary outcomes

  1. Percent reduction in affected body surface area (BSA) from baseline

    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.

    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.

Secondary outcomes

  1. Safety and Tolerability: Incidence and severity of treatment-emergent adverse events

    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.

    Time frame: Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07312604
Lead sponsor
Abeer Mohamed Abdelaziz Elkholy
Collaborators
Mansoura University Hospital
Responsible party
Abeer Mohamed Abdelaziz Elkholy (Professor of Dermatology, Faculty of Medicine, Mansoura University, Mansoura University Hospital) — Sponsor-investigator
First posted
Dec 31, 2025
Start date
Dec 9, 2025
Primary completion
Mar 9, 2026 (estimated)
Completion
Mar 9, 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

Abeer Mohamed Elkholy, MD degree of Dermatology
Contact
abeerkholy@hotmail.com
+201006210646
Nora Mohamed Abdelrazik, MD degree of Dermatology
Contact
noraeldarawany@gmail.com
+201060291029

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine

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