Evaluation of the Efficacy of the Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- antipigmenting assessment
研究概览
简要总结
This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.
详细描述
Study objective
- Assessing the antipigmenting efficacy of the routine (serum B3 + B3 retinol night cream) in women with melasma.
- Evaluation of Kligman Trio (KT) (Vitacid Plus) compared to the routine (serum B3 + B3 retinol night cream)
- Evaluation of Hydroquinone 4% (HQ 4%) compared to the routine (serum B3 + B3 retinol night cream).
- Assessment of the routine maintenance with SERUM B3 + retinol B3 night cream after 3 months of use of Klingman Trio (KT)(Vitacid plus) and HQ4%
Primary endpoint:
o Improvement of mMASI and MASI
Secondary endpoints:
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
- Double (Participant, Investigator)
盲法说明
Subjects will be randomized in three groups and will be treated differently taking into account only the original Melasma Area Severity Index (MASI) score at baseline:
• An adaptive randomization scheme (minimization method) will be used to determine the treatment group (among the 3 available) to which eligible subjects will be enrolled in. This strategy will ensure a balance between treatment groups for one important prognostic factor, identified as 'baseline MASI'. When a new subject is eligible for randomization, the algorithm verifies the average MASI of the subjects in each group. The new subject will be allocated to a group in such a way that the imbalance is minimized among the groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-65 years
- •Phototype II-V
- •50% with sensitive skin (declarative);
- •Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year
排除标准
- •Subjects under topical or systemic retinoids;
- •Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;
- •Subjects under systemic immunosuppressants and considered immune compromised
- •Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months
- •Pregnant women and/or breastfeeding women
- •Subjects with a recent change in contraception (since less than 6 months);
- •Subjects known allergy to any component of tested product;
- •Subjects not presenting with the conditions needed to comply with the protocol;
- •Subjects without any other dermatological conditions on the face
- •Subject under menopause phase with hormonal replace therapy
- •Subjects in the initial phase, change or discontinuation of hormonal treatment (estroprogesterone, cyproteron acetate, androgenic...) in the last 3 months;
- •Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- •Subjects unable to give their informed consent.
结局指标
主要结局
antipigmenting assessment
时间窗: Day 168
Melasma Area Severity Index(MASI)
次要结局
- Subject global efficay rating(Day 168)
- Investigator global efficay rating(Day 168)
- Cosmetic acceptability(Day 168)
- Evolution of quality of life(Day 156)
- transepidermal water loss(Day 168)
- skin hydration(Day 168)
- exposome questionnaire(baseline)
- Investigator Global Assessment (IGA) assessment(Day 168)
- Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)(Day 168)
- Clinical scoring hyperpigmentation(Day 168)
- Clinical scoring target lesion comparing to surrounding skin(Day 168)
- images(Day 168)
- Skin quality(Day 168)
- confocal(Day 168)
- Melasma status(baseline)
- adverse events(Day 168)
- antipigmenting assessment(Day 140)