Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Healing promoting effect of ozonated olive oil
研究概览
简要总结
This study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.
详细描述
All participants will be subjected to the following:
- Written informed consent.
- Detailed history and clinical examination and photographic documentation
- Patients with pemphigus vulgaris (epidermal skin blisters) as well as those with bullous pemphigoid (subepidermal skin blisters) will receive systemic treatment, namely; pulse steroid therapy and either mycophenolate mofetil or azathioprine
+/- monthly IV cyclophosphamide.
- Two comparable contralateral lesions will be selected in every patient, which will be randomly assigned to either ozonated oil or conventional treatment.
- Patients will apply ozonated oil to on one lesion followed by gauze compared to conventional topical gentamycin and potassium permanganate followed by gauze on the contralateral lesion. Role of topical treatment is essentially to prevent / treat secondary bacterial infection of skin erosions as well as promote wound healing by maintaining moist clean environment.
- Surface area of both lesions will be calculated using digital planimetry, prior to starting treatment and by the end of treatment; namely end of the first cycle of intravenous pulse steroids on day 6 which defines end of intervention. Percent reduction on either side will be calculated.
- For assessing disinfectant effect, swabs will be taken from the 2 selected lesions at the same intervals for assessing for bacterial as well as fungal growth.
- Patients with positive cultures for bacterial growth will be given systemic antibiotics according to culture and sensitivity
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
- •Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
排除标准
- •Age < 18 years . Pregnant/ lactating females.
研究组 & 干预措施
Ozonated olive oil
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
干预措施: Ozonated olive oil (Drug)
Topical garamycin cream
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
干预措施: Topical garamycin cream (Drug)
结局指标
主要结局
Healing promoting effect of ozonated olive oil
时间窗: 5 days per patient
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
次要结局
- Disinfectant effect of ozonated olive oil(5 days per patient)
研究者
Rania Mogawer
Consultant and lecturer of dermatology
Cairo University
