Double Blind Randomized Study of 2% Miconazol Versus 4% Hydroquinone in the Treatment for Melasma.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depigmentation of melasma lesions by Colorimetry
研究概览
简要总结
Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.
详细描述
Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment with depigmenting compounds such as hydroquinone, are still the gold standard in this condition. Miconazol has depigmented properties that could be used as part of the treatment in melasma patients. This effect is exerted by inhibiting the tyrosinase enzyme. So, the primary objective of this study is to compare the depigmenting activity of miconazole against hydroquinone.
Patients who are included in the study will be randomly assigned to receive one of the treatments, which should use for 12 weeks. The medications should be applied in the affected regions twice a day.
The evaluation of clinical improvement will be done in a blinded modality by means of the MASI score, the Global Physician Assessment, as well as colorimetry and histological melanin content. Evaluations will be held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.
At the end of the study, data will be compared concerning the former parameters. All side effects will be recorded and analysed.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Mexican women over 18 years of age
- •Dermatologic diagnostic of melasma
- •Phototype III or more
排除标准
- •Pregnant or breastfeeding
- •Postbirth, abortion in the past 6 months
- •Having an endocrine or autoimmune disease
- •Under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months
- •Currently under treatment for melasma including sunblock
- •Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months
- •Having used or are consuming photosensitizing substances, oral or topical
研究组 & 干预措施
Miconazole
OTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.
干预措施: Miconazole (Drug)
Hydroquinone
Hydroquinone 4% cream (Topical use) a depigmenting agent used as reference will be used as control. It will be applied twice a day for 9 weeks.
干预措施: Hydroquinone (Drug)
结局指标
主要结局
Depigmentation of melasma lesions by Colorimetry
时间窗: 12 weeks
Quantification of the colour change in the melasma lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark.
次要结局
- Global Physician Assessment(12 weeks)
- MASI (Melasma Area Severity Index)(12 weeks)
- Melanin content by Fontana Masson stain(12 weeks)
研究者
Juan Pablo Castanedo-Cazares
Clinical Professor. Dermatology department.
Universidad Autonoma de San Luis Potosí