Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35511, Egypt
Location status: Recruiting
NCT Number: NCT07312604
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.
Interested in participating?
Request Info10 year–60 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 35511, Egypt
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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®
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.
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.
Contact information is provided by the study sponsor or research team.
Abeer Mohamed Elkholy, MD degree of Dermatology
CONTACT
Nora Mohamed Abdelrazik, MD degree of Dermatology
CONTACT
Abeer Mohamed Abdelaziz Elkholy
Other
Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study
Acronym: IL-ImmuneRTC
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.
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