Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Clinical improvement
研究概览
简要总结
3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.
详细描述
The sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using KOH examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age> 16 years Exclusion criteria include: -pregnancy and lactation -Any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes
Steps of performance and techniques used:
- Complete history taking.
- Detailed local examination:
Local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions.
Patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with onychomycosis
排除标准
- •pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
研究组 & 干预措施
Itraconazole
all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects
干预措施: Itraconazole 200 mg (Drug)
Itraconazole + Low dose Isotretinoin
patients will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol. Treatment protocol consists of low dose isotretinoin (20mg, every other day for pediatrics) for a 3- month course. After completion of the course, treating dose of isotretinoin was maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies was permitted.
干预措施: ISOtretinoin 10 MG (Drug)
Itraconazole +Excimer light
will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).
干预措施: excimer light (Device)
结局指标
主要结局
Clinical improvement
时间窗: 6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
using onychomycosis severity index at baseline, last session and follow up vistis
Culture
时间窗: 6 month frame: Fungal culture will be done at first presentation of the patients, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Fungal culture to detect fungal cause and presence after treatment
次要结局
未报告次要终点
研究者
Mona El Radi Kamal Mohamed Emam
Principle Investigator
Zagazig University