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临床试验/NCT05269641
NCT05269641招募中不适用

The Effect of Almond Supplementation on Mild to Moderate Acne

Integrative Skin Science and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Total lesion count

研究概览

简要总结

This study will assess the effect of almond supplementation on acne and on gut health.

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
All
接受健康志愿者
是

入选标准

  • •Subjects 15 years of age until 45 years of age.
  • •The presence of mild to moderate acne based on investigator global assessment.
  • •Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.

排除标准

  • •The presence of severe acne as noted by the investigator global assessment.
  • •Those with a nut allergy.
  • •Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
  • •Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
  • •Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
  • •Individuals who have been on an oral antibiotic for acne within the previous 1 month.
  • •Individuals who are pregnant or breastfeeding.
  • •Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
  • •Oral supplementation that has nuts in it.
  • •Use of isotretinoin within the three months prior to joining the study.
  • •Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

研究组 & 干预措施

Almonds

Experimental

Daily consumption of almonds.

干预措施: Food: whole almonds (Other)

Control Snack

Placebo Comparator

Daily non-nut snack will be consumed.

干预措施: Food: non-nut snack (Other)

结局指标

主要结局

Total lesion count

时间窗: 20 weeks

Number of of inflammatory lesions, and open and closed comedones

次要结局

  • Inflammatory lesion count(20 weeks)
  • Non-inflammatory lesion count(20 weeks)
  • Investigator global assessment (IGA) of acne(20 weeks)
  • Quality of Life Survey(20 weeks)
  • Sebum excretion(20 weeks)
  • Gut microbiome assessment(20 weeks)
  • Skin microbiome diversity(20 weeks)
  • Inflammatory lesion count(12 weeks)
  • Non-inflammatory lesion count(12 weeks)
  • Investigator global assessment (IGA) of acne(12 weeks)
  • Quality of Life Survey(12 weeks)
  • Sebum excretion(12 weeks)
  • Gut microbiome assessment(12 weeks)
  • Skin microbiome diversity(12 weeks)

研究者

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

Raja Sivamani, MD MS AP

Principal Investigator

Integrative Skin Science and Research

研究点 (1)

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