TCTR20230703006已完成4 期
A Randomised, Double-blinded, Placebo-controlled Trial to investigate the Efficacy and Safety of Act 3 on the Treatment of Acne Type 3 Lesions
Rajdhevee Holistic Clinic Co., Ltd.0 个研究点目标入组 60 人开始时间: 2023年7月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •1. Healthy participant between 18 to 40 years old (inclusive).
- •2. Diagnosed with moderate1 facial Acne Type 3, characterised by inflamed
- •erythematous papules and papulopustular lesions2.
- •3. Must give informed consent prior to study enrolment and all study procedures.
- •4. Must be able to comply with study procedures and be available for all study visits.
- •5. Must be in general good health based on medical history as determined by the investigator(s) at Screening.
排除标准
- •1. Participants not diagnosed with moderate facial Acne Type 3.
- •2. Previous use of oral or topical Vitamin A acid (isotretinoin) within 3 months prior to Screening (Day -3).
- •3. Previous use of topical and systemic antibiotics within 1 month prior to Screening (Day -3).
- •4. Previous use of laser therapy within 1 month prior to Screening (Day -3).
- •5. Previous use of hormone therapy, steroids, or anti-inflammatory medicines within 1 month prior to Screening (Day -3), e.g., oral hormones, anti-androgen therapy, spironolactone, steroids, anti-inflammatory medicines.
- •6. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants interest to participate in the study.
- •7. History of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug, or any known or suspected allergies or sensitivities to any component of the Study Drug or Placebo.
- •8. History of alcohol or drug abuse that, in the opinion of the PI(s), could affect the participant safety or compliance with study.
- •9. Presence of an acute illness, as determined by the PI(s), with or without fever (forehead temperature measured with validated device greater than or equal to 37.5 degree Celsius) at Screening (Day-3) or Enrolment (Day 0).
- •10. Current use of any prescription or over-the-counter medicines within 7 days prior to Screening (Day -3), unless approved and documented by the PI(s).
- •11. Use of any other therapeutic or cosmetic products, devices or procedures that could interfere with the assessments of the treatment areas within 7 days prior to Screening (Day -3), unless approved and documented by the PI(s).
- •12. Current participation in any other interventional clinical trial or previously enrolled in an interventional clinical trial, which in the opinion of the PI(s) may interfere with the interpretation of the trial results.
- •13. Close affiliation with the PI(s), person(s) working at the trial site(s) or an employee of the sponsor (e.g., a close relative).
研究者
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