DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- improve in the level of DNA methylated
研究概览
简要总结
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
详细描述
OBJECTIVE
Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p<0.05), RA (7 vs 2 times relative expression p<0.05), and N (7 vs 1 relative expression p<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.
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
- Double (Participant, Investigator)
盲法说明
double bind
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
- •Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.
排除标准
- •Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).
- •Have received treatment in the last 2 months. Regular use of sunscreen.
研究组 & 干预措施
Control group
Macules of melasma without any treatment
干预措施: colorimetry measurement (Device)
Niacinamide group
Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
干预措施: colorimetry measurement (Device)
Niacinamide group
Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
干预措施: Niacinamide (Drug)
Retinoic acid group
Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
干预措施: Retinoic acid (Drug)
Retinoic acid group
Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
干预措施: colorimetry measurement (Device)
Sunscreen group
Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
干预措施: colorimetry measurement (Device)
Sunscreen group
Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
干预措施: sunscreen (Drug)
结局指标
主要结局
improve in the level of DNA methylated
时间窗: 8 weeks
Decrease in levels of expression of DNA methyl transferases
次要结局
- improve in the clinical severity of melasma(8 weeks)
研究者
Juan Pablo Castanedo-Cazares
Medical Doctor
Universidad Autonoma de San Luis Potosí
