Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
研究概览
简要总结
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.
To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Adult women aged between 18-65 years old.
- •Fitzpatrick phototypes I to IV.
- •Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and
- •Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
- •Breastfeeding women will not be included in the study.
- •Having given freely and expressly her informed consent.
排除标准
- •Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
- •Fitzpatrick phototype V.
- •Skin pigmentation diseases different to melasma.
- •Evidence of active cancer disease or diagnosis of cancer in the last year.
- •Those receiving any topical or oral treatment that could interfere with melasma.
- •Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
- •Evidence or suspicion of low compliance with the study visits and procedures.
- •Participation in other clinical trial simultaneously or in the previous 3 months.
研究组 & 干预措施
Hydroquinone
Hydroquinone 4% Cream will be applied in one side of the face while the other side of the face receives placebo.
Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side.
It will be applied daily, at night, during 8 weeks.
干预措施: Hydroquinone (Drug)
Placebo
Placebo cream (vehicle of Hydroquinone 4% cream), will be applied in one side of the face, while the other side receives the active treatment.
Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side.
It will be applied daily, at night, during 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
时间窗: Baseline, week 4, week 8.
Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).
次要结局
- To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.(Week 4, Week 8, Follow-up period (Week 12))