Evaluating the Therapeutic Efficacy of Intra-lesional Immunotherapy Against Recalcitrant Tinea Cruris & Corporis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent reduction in affected body surface area (BSA) from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Intra-Lesional MMR Immunotherapy (Biological)
结局指标
主要结局
Percent reduction in affected body surface area (BSA) from baseline
时间窗: 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.
次要结局
- Safety and Tolerability: Incidence and severity of treatment-emergent adverse events(Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.)
研究者
Abeer Mohamed Abdelaziz Elkholy
Professor of Dermatology, Faculty of Medicine, Mansoura University
Mansoura University Hospital