The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome in Acne.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome
研究概览
简要总结
This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline. The bacteria in the gut and on the skin will be studied to see how each treatment may affect them and whether they change the profile of the bacteria that is present.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) Diagnosis of acne vulgaris with:
- •At least 10 inflammatory lesions (papules, pustules, and nodules) up to 100 noninflammatory lesions (open and closed comedones)
- •No more than 2 nodules on the face
排除标准
- •Dermatological condition of face or facial hair that could interfere with clinical evaluations
- •Subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
- •2a) Within 2 week prior to randomization:
- •Topical acne medications such as retinoids, antibiotics, hormonal modulators
- •Topical benzoyl peroxide
- •Topical anti-inflammatories and corticosteroids
- •2b) Within 4 weeks prior to randomization:
- •Systemic antibiotics
- •Systemic acne treatments
- •Oral probiotic supplement
- •Systemic corticosteroids
- •2c) Within 12 weeks prior to randomization:
- •Systemic retinoids
- •3) Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
- •4) Individuals who are pregnant or breastfeeding.
- •5) Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months.
- •6) Individuals on finasteride or dutasteride
- •7) Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.
研究组 & 干预措施
Sarecycline Group
Half of the participants will be randomized to receive sarecycline treatment.
干预措施: Sarecycline (Drug)
Doxycycline Group
Half of the participants will be randomized to receive doxycycline treatment.
干预措施: Doxycycline (Drug)
结局指标
主要结局
Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome
时间窗: From enrollment to the end of treatment at 4 weeks.
Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment.
Change in the relative abundance of fungi/yeast in the gut microbiome
时间窗: From enrollment to the end of treatment at 4 weeks.
Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment.
次要结局
- Change in inflammatory and non-inflammatory lesions(From enrollment to the end of treatment at 4 weeks.)
- Change in the diversity of the gut microbiome: Shannon Diversity(From enrollment to the end of treatment at 4 weeks.)
- Change in investigator global assessment of acne(From enrollment to the end of treatment at 4 weeks.)
- Change in relative abundance of short chain fatty acid production genes(From enrollment to the end of treatment at 4 weeks.)
- Change in skin microbiome relative abundance(From enrollment to the end of treatment at 8 weeks.)
- Change in the skin microbiome relative abundance of fungi/yeast(From enrollement to the end of treatment at 4 weeks.)