A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 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 a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. 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 sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard in this condition.
Visible light has pigmenting properties that could be interfering with the treatment in melasma patients. So, the primary objective of this study is to compare the depigmenting adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.
Patients who are included in the study will be randomly assigned to receive one of the sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in the affected regions every 3 hours from 8AM to 5PM. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Women over 25 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 sunscreens
- •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
290-400 nm sunscreen
Sunscreen containing Mexoryl SX, Mexoryl XL, Titanium Dioxide, Octocrylene, Tinosorb S, Avobenzone, and Ethylhexyl triazone.
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
干预措施: 290-400 nm sunscreen (Drug)
290-800 nm sunscreen
Sunscreen containing Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, and iron oxide.
Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
干预措施: 290-800 nm sunscreen (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 value is pure white, 100 value is total black.
次要结局
- Global Physician Assessment(12 weeks)
- MASI (Melasma Area Severity Index)(12 weeks)
- Melanin content by histologic quantification.(12 weeks)
研究者
Juan Pablo Castanedo-Cazares
Dermatology assistant professor
Universidad Autonoma de San Luis Potosí