Photobiomodulation With Yellow Light in the Treatment of Melasma: Clinical Trial, Randomized, Controlled, Double Blind.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- MASI (Melasma Area and Severity Index)
研究概览
简要总结
Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. A total of 54 female participants, phototype scale Fitzpatrick ll - lV will be recruited which will be distributed among two groups: Light + placebo Home Care cosmetic product and Light sham + Home Care cosmetic product with tranexamic acid. The treatments will consist of 90 days, with application of photobiomodulation (PBM) once a week and application of the cosmetic product twice a day.
详细描述
This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of Melasma compared to the effect of tranexamic acid. The sample will be divided into 2 groups: Group 1 will receive PBM with amber Light Emitting Diode (LED) (DMC E-Light ABR), 20 J/cm² and placebo topical cosmetic for use in home care; Group 2 will receive PBM sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. A total of 54 women with facial Melasma, aged 35 to 50 will be included. The treatments will consist of 12 sessions, once a week for 3 months. The severity of Melasma will be evaluated through the Melasma Area and Severity Index (MASI index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (MELASQoL-PB) will also be made.
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, Outcomes Assessor)
盲法说明
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Feminine gender
- •Age between 35 to 50 years
- •Phototypes l to lV of the Fitzpatrick scale
- •Facial melasma
- •Healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses)
排除标准
- •Pre-existing systemic diseases, autoimmune diseases, digestive system disease
- •Polycystic ovary
- •Isotretinoin drug use (less than 6 months)
- •Sequelae of an accident on the face that interferes with the facial treatment
- •Undertakes any treatment for topical or oral Melasma at the time of the research or less than 3 months ago
- •Uses retinoic acid, vitamin A derivatives, photosensitizing drugs
- •Skin pathologies on the face
- •Glaucoma, cataract, cancer patients, pregnant women, lactating women
- •Uses oral or intrauterine contraceptives (IUD)
- •Thyroid disorders
- •Use of hormone replacement
- •Bacterial, viral and fungal infections
- •Tendency to form keloids
结局指标
主要结局
MASI (Melasma Area and Severity Index)
时间窗: After the treatments (week 12).
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
次要结局
- Photography(Before (week 0), at half (week 6) and after treatment (week 12).)
- Final global diagnosis of the skin.(Before (week 0), at half (week 6) and after treatment (week 12).)
- The MELASQoL questionnaire, (Melasma Quality of Life Scale)(Before (week 0), at half (week 6) and after treatment (week 12).)
- Corneomelametry(Before (week 0), at half (week 6) and after treatment (week 12).)
- Adverse Effects(At half (week 6) and after treatment (week 12).)
研究者
Christiane Pavani
Clinical Professor
University of Nove de Julho