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临床试验/NCT05594472
NCT05594472招募中3 期

Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Mogawer

Consultant and lecturer of dermatology

Cairo University

研究点 (1)

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