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临床试验/NCT03392623
NCT03392623已完成早期 1 期

DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.

Universidad Autonoma de San Luis Potosí0 个研究点目标入组 28 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Other

Macules of melasma without any treatment

干预措施: colorimetry measurement (Device)

Niacinamide group

Experimental

Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks

干预措施: colorimetry measurement (Device)

Niacinamide group

Experimental

Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks

干预措施: Niacinamide (Drug)

Retinoic acid group

Experimental

Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks

干预措施: Retinoic acid (Drug)

Retinoic acid group

Experimental

Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks

干预措施: colorimetry measurement (Device)

Sunscreen group

Placebo Comparator

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Pablo Castanedo-Cazares

Medical Doctor

Universidad Autonoma de San Luis Potosí

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