A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,785
- 试验地点
- 1
- 主要终点
- inflammatory lesions
研究概览
简要总结
Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.[1] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.[2, 3] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate acne
- •presence of postinflammatory hyperpigmentation lesions
- •phototype IV to VI
排除标准
- •less than 18 years
- •severe acne
结局指标
主要结局
inflammatory lesions
时间窗: Month 2
lesion count
PAHPI: post-acne hyperpigmentation index
时间窗: Month 2
post-acne hyperpigmentation index from \<3mm to \>10mm
seborrhoea level
时间窗: Month 2
visual analog scale 0=none to 10= very severe
acne severity
时间窗: Month 2
GEA (Global evaluation of acne) scale 0=none to 5=very severe
non-inflammatory lesions
时间窗: Month 2
lesion count
次要结局
- Investigator satisfaction acne(Month 2)
- Investigator satisfaction(Month 2)
- Patient satisfaction PAHPI(Month 2)
- Patient: Skin quality(Month 2)
- Patient satisfaction acne(Month 2)