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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392623
Enrollment
28
Registered
2018-01-08
Start date
2015-01-01
Completion date
2016-12-01
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

Epigenetics, Malar melasma,

Brief summary

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

Detailed description

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.

Interventions

topical administration in melasma lesions

topical administration in melasma lesions

DEVICEcolorimetry measurement

Measurement of erythema and luminosity through a colorimeter

DRUGsunscreen

topical administration in melasma lesions

Sponsors

Universidad Autonoma de San Luis Potosí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

double bind

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
improve in the level of DNA methylated8 weeksDecrease in levels of expression of DNA methyl transferases

Secondary

MeasureTime frameDescription
improve in the clinical severity of melasma8 weeksdecrease in the MASI score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026