EVALUATION of the EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA OVER 3 MONTHS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Change in mMASI scoring
研究概览
简要总结
This study aims at assessing the non-inferiority of tested formula facial serum (2039125 03) versus hydroquinone 4% over 3 months for treatment and then 3 months for maintenance ofwomen subjects presenting facial melasma.
详细描述
Topical treatments are usually used first line. Among a high number of molecules claiming a depigmenting effect, hydroquinone used at various concentrations (typically 2 to 5%) is the most widely used skin depigmenting product and is considered, up to now, the gold standard when used at 4-5%.
Hydroquinone is sometimes combined in the Kligman's trio, with topical tretinoin and topical steroids, which remains the best initial treatment for melasma in terms of efficacy.
This randomized , two-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults (over 18 y.o.) (preference 18-50 y.o.);
- •Phototypes I to IV;
- •Melasma epidermal or mixed (exclude dermal melasma);
- •Ready to protect as much as possible from the sun for the duration of the study;
- •Ready to avoid contraindicated products (irritants, other depigmenting agents);
- •Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form.
排除标准
- •Subjects with dermal melasma (wood lamp at inclusion);
- •Subjects who has already use of hydroquinone 4% in the past year;
- •Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
- •Pregnant or breastfeeding women or pregnancy plans;
- •Subjects applying irritants (such as peeling, acid..) (2 weeks wash out);
- •Subjects under active treatment of melasma (including topicals or procedures) within the last 2 weeks;
- •Subjects using drugs that can induce melasma such as antiepileptics (1 month wash out);
- •Subjects using other products claiming a depigmenting activity (1 month wash out);
- •Subjects with other dermatosis of the face or known photosensitivity;
- •All types of topical treatment applied to the face (wash out of 2 weeks)
- •Subjects without any facial procedure planned during the course of the study
- •Subjects under phototherapy (1 month wash out)
- •Subjects hypersensitivity to the products of the study
- •Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction
- •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.
- •Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics, or medication
- •Participation in another clinical study
- •Employee of the sponsor or the study site
研究组 & 干预措施
Group TP: Tested product
Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma
干预措施: Experimental: Group TP (Other)
Group HQ: Hydroquinone 4%
Subjects (aged over 18 years) with mild to severe facial epidermal or mixed melasma
干预措施: Active Comparator: Group HQ: Hydroquinone 4% (Drug)
结局指标
主要结局
Change in mMASI scoring
时间窗: From baseline to 3months
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 4).
Evaluation of Global Tolerance
时间窗: From 1month to 3 months
The investigator evaluates the tolerance using a 5-point skin reaction scale (0 represent No local intolerance ; 4 represent a Very severe signs or symptoms of intolerance)
次要结局
- Change in Investigator's Global Assessment (IGA)(From baseline to3 months)
- Change in Subject Global Assessment of Improvement (SGAI)(From 1month to 3 months)
- Change of Quality of life(From 1month to 3 months)
- Change of stigmatization evaluation(From 1month to 3 months)