Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Dermatophytosis Severity Score (DSS)
研究概览
简要总结
This study aims to assess the efficacy of narrow-band ultraviolet B (NB-UVB) phototherapy as a standalone treatment in patients with resistant and recurrent tinea.
To evaluate the clinical and mycological improvement in response to NB-UVB therapy compared to standard anti-fungal treatment alone.
详细描述
Randomized, parallel-group, two-arm clinical trial. Arm A (NB-UVB group): Patients receive narrowband UVB phototherapy only.
Arm B (Itraconazole + Terbinafine group): Patients receive combined oral itraconazole and terbinafine.
Allocation will be 1:1 using concealed randomization.
Intervention:
Intervention (Arm A):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Both sexes.
- •Clinical diagnosis of tinea corporis or cruris.
- •Failure of ≥4 weeks of systemic antifungal therapy (e.g., terbinafine or itraconazole).
- •No antifungal (topical or systemic) or corticosteroid treatment in the 2 weeks preceding enrollment.
- •Recurrent infection (≥2 relapses in the past 6 months)
- •Positive KOH microscopy and culture at baseline
排除标准
- •Photosensitivity disorders or photosensitizing medications.
- •Xeroderma pigmentosa, LE or other photosensitive dermatoses. dermatomyositis.
- •Other skin conditions (psoriasis, eczema, etc.).
- •Known autoimmune diseases, immunosuppression, or coagulopathies..
研究组 & 干预措施
NBUVB
Type of phototherapy
干预措施: NBUVB (Device)
Medical treatment
combined oral itraconazole and terbinafine.
干预措施: Itraconazole + terbinafine (Drug)
结局指标
主要结局
Dermatophytosis Severity Score (DSS)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Hagar El Sayed
Dr Hagar El Sayed Abd El Ghani Anter
Cairo University