Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Post Inflammatory Hyperpigmentation (PIHP) Change
研究概览
简要总结
The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiethnic subjects
- •18 to 50 YO
- •Phototype III-VI
- •All skin types
- •50% with sensitive skin (declarative)
- •Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale
- •Mild active acne (less than 10 retention and 5 inflammatory lesions)
- •Agreeing not to change their lifestyle during the study period.
- •Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.
- •Available to follow the study
- •Agreeing to participate and having signed the informed consent
排除标准
- •Moderate to severe active acne
- •Patients under topical or systemic retinoids
- •Patients under systemic immunosuppressants
- •Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
- •Patients treated with facial procedures within the last 3 months
- •Pregnancy
- •Patient with a recent change in contraception (since less than 6 months)
- •Known allergy to any component of tested product
- •Not presenting with the conditions needed to comply with the protocol.
- •Unable to give their informed consent
- •Not available to follow the study in its entirety
研究组 & 干预措施
Control Group
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
干预措施: Sunscreen (Other)
Liftactiv B3
Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.
干预措施: Liftactiv B3 (Drug)
结局指标
主要结局
Post Inflammatory Hyperpigmentation (PIHP) Change
时间窗: Baseline, 1 month, 2 months and 3 months
Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.
次要结局
- Change in Global Efficacy Assessment(1 month, 2 months, and 3 months)
- Change in the Investigators Global Assessment (IGA) Scale(Baseline, 1 month, 2 months and 3 months)
- Change in Skin Condition Evaluation Scores(Baseline, 1 month, 2 months and 3 months)
- Exposome Questionnaire(Baseline and 3 months)
- Change in Cosmeticity Questionnaire and Acceptability(1 month, 2 months, and 3 months)
- Change in Global Tolerance Score(1 month, 2 months, and 3 months)
研究者
Leigh Nattkemper
Research Assistant Professor
University of Miami