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临床试验/NCT06018168
NCT06018168已完成不适用

A Randomized, Controlled Study Evaluating the Efficacy of a Skincare Routine and Acne Supplement or a Skincare Routine Alone on Improving Acne and Other Symptoms of PMS

Clearstem Skincare2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Changes in participants perception of facial acne. [Baseline to Week 24]

研究概览

简要总结

This study aims to evaluate the efficacy of the MINDBODYSKIN Hormonal Acne Supplement and a prescribed skincare routine of 6 products on facial acne and on symptoms of PMS, compared to a skincare routine of 6 products alone. This study will last for 24 weeks. The study will be conducted as a randomized, controlled trial in which participants will be split into two groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN supplement in combination with the skincare routine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 18 years of age or older Have regular acne Have any noticeable PMS symptoms like stress, bloating, mood swings, acne Be generally healthy (i.e. don't live with any uncontrolled chronic disease besides acne).
  • Have a body weight of >120 lbs.

排除标准

  • Have any pre-existing conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Be currently using any prescribed medications for their face Anyone with any known severe allergic reactions Women who are pregnant, breastfeeding or attempting to become pregnant Anyone unwilling to follow the study protocol

研究组 & 干预措施

Group Two: Skincare Routine + Supplement

Active Comparator

Participants will follow instructions for the skincare routine AND will take a daily supplement.

干预措施: Skincare Routine (Other)

Group One: Skincare Routine Only

Active Comparator

Participants will follow instructions for the skincare routine only. Participants will complete the routine twice daily.

干预措施: Skincare Routine (Other)

Group Two: Skincare Routine + Supplement

Active Comparator

Participants will follow instructions for the skincare routine AND will take a daily supplement.

干预措施: MINDBODYSKIN Supplement (Dietary Supplement)

结局指标

主要结局

Changes in participants perception of facial acne. [Baseline to Week 24]

时间窗: 24 weeks

Survey-based assessment (0-5 scale) of participants perception of changes to their facial acne.

Changes in facial acne. [Baseline to Week 24]

时间窗: 24 weeks

Participants will provide photos of their face for virtual skin grading by dermatologist.

Changes in blood serum levels of vitamin A. [Baseline to Week 24]

时间窗: 24 weeks

Participants will undergo blood draws to assess blood serum levels of vitamin A.

次要结局

  • Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24](24 weeks)

研究者

发起方
Clearstem Skincare
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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