Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Total inflammatory acne lesions
研究概览
简要总结
The goal of this clinical trial is to investigate the effectivity and safety of mild to moderate acne vulgaris therapy using Zingiber officinale 5 % transdermal patch. Researcher will compare both half faces (split face); one side as treatment side where patch is used, and another side as control. Patient will be asked to apply tretinoin 0,025% cream nightly. After applying tretinoin 0,025% on whole face, patient will be asked to apply patch on a pustule on one half face, and no patch will be used on another half face.
Total lesion count will be assessed before treatment and 21 days after treatment. Specimen for skin microbiome and interleukin examination will be collected before and 21 days after treatment.
详细描述
Current acne vulgaris treatment include antibiotic, retinoic acid, and benzoyl peroxide. The use of antibiotic has been linked to antibiotic resistant problem. Research also has shown the association between acne vulgaris and skin microbiome. Therefore, new treatment for acne vulgaris that has good effect on skin microbiome is needed.
Z. officinale is an herb that commonly used in traditional medicine. Researches have shown that it has anti-inflammation activity and antibiotic activity to Cutibacterium acnes. On the other hand, the prebiotic potency of Z. officinale on gut microbiome has also been investigated.
This randomized controlled trial shall include 26 mild to moderate acne vulgaris patients according to inclusion and exclusion criteria. Patches will be given every 5 days as researcher follow up patient condition. Patient photograph will be taken before treatment, on follow up day, and after 21 days treatment. Skin microbiome specimen will be collected using skin swab method. Secret from a chosen pustule will be collected for interleukin examination.
During clinical trial, patient will use non comedogenic sunscreen and soap from researcher. Patient will be asked to report to researcher if there is side effect of treatment.
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
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •15-45 years old
- •mild to moderate acne vulgaris according to Lehmann criteria
- •minimal 3 pustules on face that are distributed on right and left sides
排除标准
- •history of allergy to ingredients that is used in research
- •history of topical acne medication and steroid in the last 2 weeks
- •history of medical aesthetic procedure such as laser and chemical peeling in the last 2 weeks
- •history of oral antibiotic therapy in the last 6 weeks
- •history of oral isotretinoin therapy in the last 6 months
- •history of probiotic consumption in the last 3 weeks
- •pregnancy and lactation
研究组 & 干预措施
tretinoin 0.025% + Z.officinale patch
Z. officinale 0.05% application on pustule after tretinoin 0.025% application
干预措施: tretinoin 0.025% + Z. officinale patch (Drug)
tretinoin 0.025% cream
No Z. officinale patch
干预措施: tretinoin 0.025% cream (Drug)
结局指标
主要结局
Total inflammatory acne lesions
时间窗: At 0 and after 3 weeks duration of trial
Total inflammatory acne lesions are the total of papules, pustules, nodules, and cysts.
次要结局
- Level of Interleukin-1 from pustule(At 0 and after 3 weeks duration of trial)
- Skin microbiome(At 0 and after 3 weeks duration of trial)
研究者
Rini Amanda Carolina Saragih
Principle investigator
Hasanuddin University