Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of Azithromycin in treating pityriasis lichenoides chronica
研究概览
简要总结
Primary outcome:
The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB).
Secondary outcomes:
- To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.
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 (Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
- •Age: > 6 years
- •Both sexes.
排除标准
- •Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
- •Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
- •Patients with PLC associated with classic MF.
- •Patients with known absolute contraindications to NB-UVB.
- •Patients with impaired liver and/or kidney functions.
- •Patients with history of any heart disease.
- •Patients with known hypersensitivity to Azithromycin
研究组 & 干预措施
Azithromycin
The dose of azithromycin will be 10mg/kg/day oral suspension for 3 consecutive days for pediatric patients (<12 years old) and 500mg/day in three consecutive days for adults. The cycle will be repeated every seven days (3 cycles/month) and will be repeated if required according to patient's response up to 6 cycles. Side effects of therapy will be recorded. This protocol is based on previous case reports.
干预措施: Azithromycin (Drug)
Nb UVB
Patients recruited for nbUVB phototherapy will have an initial dose of 0.3J-0.5J according to Fitzpatrick's skin type. The dosage will be increased by 0.3J in every other treatment session. The sessions will be given 3 times weekly until improvement is noted or reaching 8 weeks at the EOS. We arrived at this initial dose based on our previous experience with Egyptian patients in Kasr Alainy phototherapy unit in Dermatology Department, Cairo University.
干预措施: nbUVB (Other)
结局指标
主要结局
Efficacy of Azithromycin in treating pityriasis lichenoides chronica
时间窗: 12 months
The clinical improvement of patients with PLC will be evaluated after taking 3 to 6 cycles of azithromycin and will be compared to the clinical outcome of patients that had three sessions of nbUVB for six to eight weeks. Side effects will be documented in each group
次要结局
未报告次要终点
研究者
Amira Elbendary
Teaching assistant
Cairo University