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OpenTrials
Completed

NCT Number: NCT03392623

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

BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.

Exclusion criteria

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.

Treatment and study plan

Retinoic acid

Drug

topical administration in melasma lesions

Other names: Niacinamide, Sunscreen

colorimetry measurement

Device

Measurement of erythema and luminosity through a colorimeter

Sunscreen

Drug

topical administration in melasma lesions

Niacinamide

Drug

topical administration in melasma lesions

Primary outcomes

  1. improve in the level of DNA methylated

    Time frame: 8 weeks

    Decrease in levels of expression of DNA methyl transferases

Secondary outcomes

  1. improve in the clinical severity of melasma

    Time frame: 8 weeks

    decrease in the MASI score

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2018
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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