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临床试验/NCT05941065
NCT05941065招募中不适用

Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin

Integrative Skin Science and Research2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
C. acnes relative abundance

研究概览

简要总结

The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.

详细描述

Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females between the ages of 18 years of age until 35 years of age
  • Males must be willing to shave facial hair
  • The presence of mild to moderate non-cystic acne based on investigator global assessment

排除标准

  • Individuals who are pregnant or breastfeeding.
  • Prisoners.
  • Adults unable to consent.
  • The presence of severe acne or cysts as noted by the investigator.
  • Those who are unwilling to discontinue topical antibiotics, topical salicylic acid containing products and topical benzoyl peroxide containing products for two weeks to meet the washout criteria prior to enrolling.
  • Those who are unwilling to discontinue all facial topical products except the cleanser and the product provided in the study.
  • Individuals who have been on an oral antibiotic for acne within the previous 1 month.
  • Individuals who have changed any of their hormonal based contraception within
  • months prior to joining the study.
  • Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

结局指标

主要结局

C. acnes relative abundance

时间窗: 6 weeks

Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing

次要结局

  • Functional gene based predictive analysis of skin inflammation related genes(6 weeks)
  • Sebum excretion rate(6 weeks)
  • Tolerability Assessment Questionnaire(6 weeks)
  • Total lesion count(6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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