Evaluation of the Efficacy and Tolerability of the Tested Formula 2039125 03 BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins: Melasma, Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
研究概览
简要总结
The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
详细描述
Hyperpigmentation is a common skin condition in which the colour of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure.
Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines.
This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with before/after comparisons.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 是
入选标准
- •all phototypes
- •only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
- •female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study.
排除标准
- •female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
- •male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
- •patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
- •severe melasma, dermal melasma
- •patient with facial pigmentary disorders other than those described in inclusion criteria
研究组 & 干预措施
mild to moderate melasma
adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)
干预措施: tested product (2039125 03) (Other)
mild to moderate acne induced PIHP
adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e., less than 10 inflammatory lesions)
干预措施: tested product (2039125 03) (Other)
solar lentigo
adult patients suffering from solar lentigo with a pigmentation score > 5
干预措施: tested product (2039125 03) (Other)
结局指标
主要结局
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
时间窗: from baseline to Day84
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (markedly darker than the surrounding normal skin)
Post-Acne Hyperpigmentation Index (PAHPI)
时间窗: from baseline to Day 84
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10mm\], median lesion intensity (from 3 \[slightly darker than surrounding skin\] to 9 \[significantly darker than surrounding skin\] and number of lesions (from 1 \[1-15\] to 5 \[\> 60\]. Total score ranges from 6 to 22.
modified Melasma Area and Severity Index (mMASI) for patients with melasma
时间窗: from baseline to Day 84
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)
次要结局
- colorimetry measurements(from baseline to Day84)